Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT05058456
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2021-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'karjungi@shockwavemedical.com', 'phone': '1-510-279-4262', 'title': 'Kavita Arjungi', 'organization': 'Shockwave Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30-Days', 'eventGroups': [{'id': 'EG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 17, 'seriousNumAtRisk': 35, 'deathsNumAffected': 1, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Vascular procedure complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular procedure complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety: Major Adverse Events (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.'}], 'classes': [{'title': 'Major Adverse Events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Death', 'categories': [{'measurements': [{'value': '1', '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'}]}]}], 'analyses': [{'pValue': '<.025', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The primary safety hypothesis is: H0: ΠS \\> PGS vs. HA: ΠS ≤ PGS where ΠS is the proportion of patients who experience a MAE within 30 days of procedure and PGS is the Safety Performance Goal. All subjects in whom a Mini S IVL catheter was introduced into the vasculature will be included in the analysis (i.e., it is an intent-to-treat analysis). The hypothesis will be tested using a one-sided Exact Binomial Test at α=0.025.'}], '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 Performance: Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.'}], 'classes': [{'title': 'Technical Success', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Any Serious Flow-Limiting Dissection (D-F)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Residual Stenosis of less than or equal to 50%', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.025', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The primary effectiveness hypothesis is: H0: ΠE ≤ PGE vs. HA: ΠE \\> PGE, where ΠE is the proportion of target lesions with technical success and PG is the effectiveness Performance Goal. One-sided statistical significance level of 0.025 = α. The hypothesis will be tested using a one-sided Exact Binomial Test.'}], 'paramType': 'NUMBER', 'timeFrame': 'Peri-Procedural', 'description': 'Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Angiographic Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', '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': '35', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.'}], 'classes': [{'title': 'IVL Technical Success (Post-dilatation)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Any Serious Flow-Limiting Dissection (D-F)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Residual Stenosis ≤ 50%', 'categories': [{'measurements': [{'value': '31', '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, 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': '35', 'groupId': 'OG000'}]}, {'units': 'Javelin Catheters', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', '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 Catheters', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Javelin Catheters', 'denomUnitsSelected': 'Javelin Catheters'}, {'type': 'SECONDARY', 'title': 'Technical Success (Final)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.'}], 'classes': [{'title': 'IVL Technical Success (Final)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Any Serious Flow-Limiting Dissection (D-F)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Residual Stenosis ≤ 30%', 'categories': [{'measurements': [{'value': '25', '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': '2025-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': '30 Days Post-Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'End of Study data not yet due for release', 'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'End of Study data not yet due for release', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single-arm', 'description': 'Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.3', 'spread': '8.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', '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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '32', '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': 'New Zealand', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-21', 'size': 1707607, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-15T15:31', 'hasProtocol': True}, {'date': '2024-07-08', 'size': 8808951, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-14T11:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2021-09-16', 'resultsFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-21', 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety: Major Adverse Events (MAE)', '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 Performance: Technical Success', 'timeFrame': 'Peri-Procedural', 'description': 'Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion 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, 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, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, single-arm feasibility study to assess the safety and performance 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': "Inclusion Criteria:\n\n-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\nExclusion Criteria:\n\n\\- General 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. 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 treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g. embolism).\n19. Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to 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': 'NCT05058456', 'briefTitle': 'Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shockwave Medical, Inc.'}, 'officialTitle': 'Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System', 'orgStudyIdInfo': {'id': 'CP 65324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-arm', 'interventionNames': ['Device: Shockwave Medical Mini S Peripheral IVL Catheter']}], 'interventions': [{'name': 'Shockwave Medical Mini S Peripheral IVL Catheter', 'type': 'DEVICE', 'description': 'The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.', 'armGroupLabels': ['Single-arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nedlands', 'state': 'Perth', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Perth', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shockwave Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}