Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-17 @ 2:59 AM
Study NCT ID:
NCT05858905
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2023-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jpopp@shockwavemedical.com', 'phone': '1-510-279-4262', 'title': 'Josh Popp', 'organization': 'Shockwave Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30-Days post-procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 20, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.'}], 'classes': [{'title': 'Major Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Clinically-Driven Target Lesion Revascularization (CD-TLR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unplanned Target Limb Major Amputation (Above the Ankle)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Major Adverse Events (MAE) at 30 days defined as a composite of:\n\n* Cardiovascular death\n* Clinically-Driven Target Lesion Revascularization (CD-TLR)\n* Unplanned Target Limb Major Amputation (Above the Ankle)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Primary Effectiveness Endpoint - Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.'}], 'classes': [{'title': 'Technical Success', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Any Serious Flow-Limiting Dissection (D-F)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Residual Stenosis Less Than or Equal to 50%', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Peri-Procedural, immediately after all therapy of the target lesion was completed.', 'description': 'Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions', 'populationDescription': 'Analysis was performed at the lesion level, where 55 subjects had 63 target lesions with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Serious Angiographic Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Peri-Procedural', 'description': 'Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'SECONDARY', 'title': 'IVL Technical Success (Post- Dilatation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.'}], 'classes': [{'title': 'IVL Technical Success (Post-dilatation)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Any Serious Flow-Limiting Dissection (D-F)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Residual Stenosis ≤ 50%', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Peri-Procedural', 'description': 'Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, as assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'IVL Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Javelin Devices', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Peri-Procedural', 'description': 'Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter.', 'unitOfMeasure': 'Javelin Devices', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Javelin Devices', 'denomUnitsSelected': 'Javelin Devices'}, {'type': 'SECONDARY', 'title': 'Technical Success (Final)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.'}], 'classes': [{'title': 'IVL Technical Success (Final)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Any Serious Flow-Limiting Dissection (D-F)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Residual Stenosis ≤ 30%', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Peri-Procedural', 'description': 'Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'SECONDARY', 'title': 'MAEs at 6-months Post Procedure', 'timeFrame': '6 Months Post-Procedure', 'description': 'Major Adverse Events (MAEs) at 6 months defined as a composite of:\n\n* Cardiovascular Death\n* Clinically-driven Target Lesion Revascularization\n* Unplanned Target Limb Amputation (Above the Ankle)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-11'}, {'type': 'SECONDARY', 'title': 'MAEs at 12-months Post Procedure', 'timeFrame': '12 Months Post-Procedure', 'description': 'Major Adverse Events (MAEs) at 12 months defined as a composite of:\n\n* Cardiovascular Death\n* Clinically-driven Target Lesion Revascularization\n* Unplanned Target Limb Amputation (Above the Ankle)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-11'}, {'type': 'SECONDARY', 'title': 'Primary Patency at 12-Months', 'timeFrame': '12-Months Post Procedure', 'description': '* Above the knee lesions: freedom from ≥50% restenosis as determined by Duplex Ultrasound (DUS) and freedom from Clinically-Driven Target Lesion Revascularization (CD-TLR)\n* Below the knee lesions: freedom from both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a CD-TLR', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-11'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': '30 Days Post-Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'End of Study data not yet due for release', 'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.\n\nIntravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-12', 'size': 1134696, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-15T15:32', 'hasProtocol': True}, {'date': '2024-07-08', 'size': 8808951, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-13T17:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2023-05-05', 'resultsFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-10', 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days', 'timeFrame': '30 Days', 'description': 'Major Adverse Events (MAE) at 30 days defined as a composite of:\n\n* Cardiovascular death\n* Clinically-Driven Target Lesion Revascularization (CD-TLR)\n* Unplanned Target Limb Major Amputation (Above the Ankle)'}, {'measure': 'Primary Effectiveness Endpoint - Technical Success', 'timeFrame': 'Peri-Procedural, immediately after all therapy of the target lesion was completed.', 'description': 'Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.'}], 'secondaryOutcomes': [{'measure': 'Serious Angiographic Complications', 'timeFrame': 'Peri-Procedural', 'description': 'Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory'}, {'measure': 'IVL Technical Success (Post- Dilatation)', 'timeFrame': 'Peri-Procedural', 'description': 'Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, as assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).'}, {'measure': 'IVL Device Success', 'timeFrame': 'Peri-Procedural', 'description': 'Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter.'}, {'measure': 'Technical Success (Final)', 'timeFrame': 'Peri-Procedural', 'description': 'Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory'}, {'measure': 'MAEs at 6-months Post Procedure', 'timeFrame': '6 Months Post-Procedure', 'description': 'Major Adverse Events (MAEs) at 6 months defined as a composite of:\n\n* Cardiovascular Death\n* Clinically-driven Target Lesion Revascularization\n* Unplanned Target Limb Amputation (Above the Ankle)'}, {'measure': 'MAEs at 12-months Post Procedure', 'timeFrame': '12 Months Post-Procedure', 'description': 'Major Adverse Events (MAEs) at 12 months defined as a composite of:\n\n* Cardiovascular Death\n* Clinically-driven Target Lesion Revascularization\n* Unplanned Target Limb Amputation (Above the Ankle)'}, {'measure': 'Primary Patency at 12-Months', 'timeFrame': '12-Months Post Procedure', 'description': '* Above the knee lesions: freedom from ≥50% restenosis as determined by Duplex Ultrasound (DUS) and freedom from Clinically-Driven Target Lesion Revascularization (CD-TLR)\n* Below the knee lesions: freedom from both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a CD-TLR'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intravascular Lithotripsy'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "General Inclusion Criteria\n\n1. Age of subject is ≥ 18 years.\n2. Subject is able and willing to comply with all assessments in the study.\n3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.\n4. Estimated life expectancy \\> 1 year.\n5. Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).\n\n Angiographic Inclusion Criteria\n6. One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs.\n7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate.\n8. Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate.\n9. Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone.\n10. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \\> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \\<50mm in length.\n\nGeneral Exclusion Criteria\n\n1. Rutherford Clinical Category 0, 1 and 6 (target limb).\n2. History of endovascular or surgical procedure on the target limb within the last 30 days or planned within 30 days of the index procedure, with the exception of toe amputation. Note: inflow treatment of non-target lesions is allowed providing successful treatment.\n3. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.\n4. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.\n5. Subject has known allergy to urethane, nylon, or silicone.\n6. Myocardial infarction within 60 days prior to enrollment.\n7. History of stroke within 60 days prior to enrollment.\n8. Subject has acute or chronic renal disease with eGFR \\<30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.\n9. Subject is pregnant or nursing.\n10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.\n11. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.\n12. Covid-19 diagnosis within 30 days.\n13. Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure.\n14. Planned major amputation of target limb.\n15. Acute limb ischemia.\n16. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).\n17. Subject already enrolled into this study.\n\n Angiographic Exclusion Criteria\n18. Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries, defined as ≤30% residual stenosis with no serious angiographic complications (e.g. embolism).\n19. Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to treatment of target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism).\n20. Target lesion includes in-stent restenosis.\n21. Evidence of aneurysm or thrombus in target vessel.\n22. No calcium or mild calcium in the target lesion.\n23. Target lesion within native or synthetic vessel grafts.\n24. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations."}, 'identificationModule': {'nctId': 'NCT05858905', 'acronym': 'FORWARD PAD', 'briefTitle': 'FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shockwave Medical, Inc.'}, 'officialTitle': 'Forward-Shifted Intravascular Lithotripsy (IVL) Technology in a Prospective, Multi-center, Single-arm Investigational Device Exemption (IDE) Study', 'orgStudyIdInfo': {'id': 'CP 67398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JAVELIN Study Catheter', 'description': 'The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.', 'interventionNames': ['Device: Intravascular Lithotripsy']}], 'interventions': [{'name': 'Intravascular Lithotripsy', 'type': 'DEVICE', 'description': 'The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.', 'armGroupLabels': ['JAVELIN Study Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital and Clinics (SHC)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80023', 'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Heart and Vein Center', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'HCA Florida Blake Hospital', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Memorial Healthcare, Inc.', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '52722', 'city': 'Bettendorf', 'state': 'Iowa', 'country': 'United States', 'facility': 'UnityPoint Health Trinity Bettendorf Hospital', 'geoPoint': {'lat': 41.52448, 'lon': -90.51569}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Cardiovascular Medicine PC', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '20832', 'city': 'Olney', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Montgomery Medical Center', 'geoPoint': {'lat': 39.15316, 'lon': -77.06692}}, {'zip': '02740', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Southcoast Hospitals Group', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Medical Center', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28202', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Radiology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Research Center at The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '74006', 'city': 'Bartlesville', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Ascension St. John Jane Phillips Hosptial', 'geoPoint': {'lat': 36.74731, 'lon': -95.98082}}, {'zip': '19096', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Institute for Medical Research', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'The Heart Hospital Baylor', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Vascular Specialists', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Medical Center', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '53211', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Ascension Columbia St. Mary's", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shockwave Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}