Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 9:20 PM
Study NCT ID:
NCT05021757
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Disrupt CAD III Post-Approval Study (PAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rrandoll@shockwavemedical.com', 'phone': '408.577.7856', 'title': 'Randee Randoll', 'organization': 'Shockwave Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to hospital discharge, approximately 24-48 hours', 'description': 'In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.', 'eventGroups': [{'id': 'EG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort. A minimum of 150 patients with 30-day follow-up will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter', 'otherNumAtRisk': 1212, 'deathsNumAtRisk': 1212, 'otherNumAffected': 0, 'seriousNumAtRisk': 1212, 'deathsNumAffected': 3, 'seriousNumAffected': 35}], 'seriousEvents': [{'term': 'Coronary Artery Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Significant Coronary Artery Dissection (C and above)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Bleeding - Access Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Bleeding - Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Bleeding - Hematoma at Access Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Bleeding - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Bleeding - Retroperitoneal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'New Requirement for Dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Other Vascular Complications Requiring Treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}, {'term': 'Stroke - Ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACC NCDR, SNOMED CT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All-cause Death Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With IVL-related Ventricular Arrhythmia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Information on IVL-specific data points were collected on a separate optional IVL Auxiliary data collection form in the CathPCI Registry. There were 153 subjects in the PAS cohort with available IVL Auxiliary data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With IVL Balloon Loss of Pressure/Rupture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Information on IVL-specific data points were collected on a separate optional IVL Auxiliary data collection form in the CathPCI Registry. There were 153 subjects in the PAS cohort with available IVL Auxiliary data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Information on IVL-specific data points were collected on a separate optional IVL Auxiliary data collection form in the CathPCI Registry. There were 153 subjects in the PAS cohort with available IVL Auxiliary data.'}, {'type': 'PRIMARY', 'title': 'Number of IVL-related Pacing Issues in Patients With PPM/ICD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours', 'description': 'Events that may indicate an adverse device interaction including inappropriate inhibition of pacing during IVL device utilization, inappropriate ICD shock during IVL device utilization (for ICD patients only), and the need for device re-programming associated with IVL use (during or post procedure).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Information on IVL-specific data points in PPM/ICD patients were collected on a separate optional IVL Auxiliary data collection form in the CathPCI Registry. There were 12 subjects with PPM/ICD devices in the PAS cohort with available IVL Auxiliary data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1212'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1212'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.\n\nShockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'spread': '9.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '330', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '882', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1060', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1212', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-04', 'size': 319282, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-31T03:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1212}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2021-08-03', 'resultsFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-31', 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Death Rate', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours'}, {'measure': 'Number of Participants With Procedure-related Adverse Events', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours'}, {'measure': 'Number of Participants With IVL-related Ventricular Arrhythmia', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours'}, {'measure': 'Number of Participants With IVL Balloon Loss of Pressure/Rupture', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours'}, {'measure': 'Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours'}, {'measure': 'Number of IVL-related Pacing Issues in Patients With PPM/ICD', 'timeFrame': 'Up to hospital discharge, approximately 24-48 hours', 'description': 'Events that may indicate an adverse device interaction including inappropriate inhibition of pacing during IVL device utilization, inappropriate ICD shock during IVL device utilization (for ICD patients only), and the need for device re-programming associated with IVL use (during or post procedure).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intravascular Lithotripsy', 'Percutaneous Coronary Intervention'], 'conditions': ['Coronary Artery Disease', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.', 'detailedDescription': 'Subject Population: Patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study. Approximately 1000 patients in the CathPCI Registry® (including a minimum of 30 patients with permanent pacemakers \\[PPM\\] or implantable cardioverter defibrillators \\[ICDs\\]) will be enrolled. Subjects will be followed through discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is ≥18 years of age\n2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI\n3. Left ventricular ejection fraction \\>25% within 6 months\n4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure\n5. LAD, RCA or LCX (or of their branches) with:\n\n * Stenosis of ≥70% and \\<100% or\n * Stenosis ≥50% and \\<99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR \\<0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²\n6. The lesion length must not exceed 40 mm\n7. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)\n8. Evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location\n\nExclusion Criteria:\n\n1. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure\n2. New York Heart Association (NYHA) class III or IV heart failure\n3. Renal failure with serum creatinine \\>2.5 mg/dL or chronic dialysis\n4. Subjects in cardiogenic shock or with clinical evidence of acute heart failure\n5. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft\n6. Previous stent within target lesion (in-stent restenosis)'}, 'identificationModule': {'nctId': 'NCT05021757', 'briefTitle': 'Disrupt CAD III Post-Approval Study (PAS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shockwave Medical, Inc.'}, 'officialTitle': 'New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter', 'orgStudyIdInfo': {'id': 'CP 64647'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Disrupt CAD III PAS Cohort', 'description': 'Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.', 'interventionNames': ['Device: Shockwave C2 Coronary IVL']}], 'interventions': [{'name': 'Shockwave C2 Coronary IVL', 'type': 'DEVICE', 'description': 'PCI procedure using a Shockwave C2 coronary IVL catheter', 'armGroupLabels': ['Disrupt CAD III PAS Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'American College of Cardiology/National Cardiovascular Data Registry (NCDR)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shockwave Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}