Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 6:28 AM
Study NCT ID:
NCT04600934
Status:
WITHDRAWN
Last Update Posted:
2024-09-03
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shockwave Assisted Large Bore Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'slow enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2020-10-19', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful advancement of planned large bore access device', 'timeFrame': 'Day 1', 'description': 'Technical success-defined as successful advancement of planned large bore access device without use of additional adjuncts (stenting, repeat shockwave treatment, high pressure balloon, alternative access pathway)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vascular Surgery'], 'conditions': ['Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). Each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging.\n\nThe intervention the use of the Shockwave Medical, Inc. Peripheral Lithoplasty® System to achieve large bore access in patients whose vessels fall outside of the IFU suggested dimensions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Indicated for planned procedure requiring large bore (\\>12 French sheath) access\n* Mental capacity to provide informed consent\n* Iliac access vessel demonstrates \\>50% circumferential calcium\n* Iliac access vessel demonstrates maximum inner lumen diameter less than IFU for device required\n* Iliac access vessel demonstrates maximum outer wall diameter greater than or equal to IFU for device required\n* Preoperative CT angiogram, \\</= 5mm slices\n* Preoperative ABI/TP\n* Unsuccessful delivery of large bore sheath without adjunctive intervention\n\n o Definition of unsuccessful = operator assessment of the following\n* Visible distortion of iliac artery calcification under fluoroscopy without forward progress of device\n* Adverse forward pressure application by operator\n* Failure of device to track with external pressure applied to abdomen\n* Patient intolerance of advancement (pain response) in awake patient\n\nExclusion Criteria:\n\n* Contraindicated for antiplatelet therapy (aspirin or plavix)\n* Planned iliofemoral surgical reconstruction in next 30 days\n* Prior common or external iliac artery stent placement\n* Prior aorto-iliac, aorto-femoral, or iliofemoral bypass present\n* Iliac access vessel demonstrates maximum outer wall diameter less than IFU for device required\n* Inability to obtain preoperative CTA (contrast allergy, CKD, etc)\n* Inability to traverse iliac segment with wire\n* Emergent procedure'}, 'identificationModule': {'nctId': 'NCT04600934', 'briefTitle': 'Shockwave Assisted Large Bore Access', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)', 'orgStudyIdInfo': {'id': '00103170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard POBA (plain old balloon angioplasty)', 'description': 'The first 50 patients will be pre-treated with standard POBA', 'interventionNames': ['Device: Plain old balloon angioplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Shockwave', 'description': 'The second 50 patients will be treated primarily with Shockwave', 'interventionNames': ['Device: Shockwave']}], 'interventions': [{'name': 'Shockwave', 'type': 'DEVICE', 'description': 'Shockwave Medical, Inc. Peripheral Lithoplasty® System', 'armGroupLabels': ['Shockwave']}, {'name': 'Plain old balloon angioplasty', 'type': 'DEVICE', 'description': 'POBA', 'armGroupLabels': ['Standard POBA (plain old balloon angioplasty)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Mathew Wooster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shockwave Medical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mathew Wooster', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}