Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT01478061
Status:
COMPLETED
Last Update Posted:
2015-07-22
First Post:
2011-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2011-10-19', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.', 'timeFrame': '12 months', 'description': 'a. Acute, midterm, and one-year graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.'}], 'secondaryOutcomes': [{'measure': 'Technical Failure Rates', 'timeFrame': 'Day 1', 'description': 'Technical failure rates when completing an anastomosis using the C-Port products.'}, {'measure': 'Technical success rate of hand-sewn', 'timeFrame': 'Day 1 and 12 months', 'description': 'The technical success rate of hand-sewn anastomoses following technical failures of the C-Port products and the hand-sewn graft patency rates and clinical sequelae at one year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Disease']}, 'descriptionModule': {'briefSummary': 'The Study plan is a post-market prospective, multi-center, open-label registry. The vein graft failure rates for the currently commercialized C-Port devices will be compared to an a priori rate taken from the peer-reviewed literature.', 'detailedDescription': 'To satisfy the requirements set forth in post-market surveillance orders issued by the US FDA to Cardica, Inc., the following outcomes will be evaluated:\n\n1. Acute, midterm, and one-year graft failure rates for coronary revascularization using the C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, and C-Port® XCHANGE™ Distal Anastomosis System when in general use in the United States compared to hand-sewn anastomoses.\n2. Technical failure rates when attempting to complete an anastomosis using the C-Port xA, FlexA, and XCHANGE Distal Anastomosis Systems.\n3. The technical success rate of hand-sewn anastomoses following technical failures of the C-Port devices and the hand-sewn graft patency rates and clinical sequelae at one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to give informed consent.\n* Willing and able to have follow-up visits and examinations.\n* Less than 80 years old.\n* Have an ejection fraction of \\>30 %.\n* Have a life expectancy of \\>1 year.\n\nPre-Operative Exclusion Criteria:\n\n* Currently participating in other clinical trials that would conflict with this protocol.\n* Unable to meet study requirements.\n* Currently pregnant.\n* Require preoperative use of an intraaortic balloon pump.\n* Have a history of a bleeding disorder or history of a thromboembolic disease requiring anticoagulation therapy.\n* Have congestive heart failure or been classified as NYHA Class IV.\n* Have an aspirin allergy or other contraindications to aspirin use.\n* Previous coronary artery bypass surgery.\n* Vasculitis or other nonatherosclerotic cause for coronary artery disease.\n\nIntra-Operative Exclusion Criteria:\n\n* At least one target vessel site where the C-Port anastomosis will be placed that is free from severe calcification or severe atheromas\n* Target vessel wall properties where the C-Port anastomosis will be placed are suitable for hand-sewn anastomosis\n* Target vessel diameter is ≥ 1.3 mm\n* Target vessel has a single wall thickness ≤ 0.75mm\n* Hemodynamically stable'}, 'identificationModule': {'nctId': 'NCT01478061', 'briefTitle': 'Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardica, Inc'}, 'officialTitle': 'Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device', 'orgStudyIdInfo': {'id': 'CP2007-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'anastomoses in blood vessels and grafts', 'interventionNames': ['Device: Anastomosis (C-Port® )']}], 'interventions': [{'name': 'Anastomosis (C-Port® )', 'type': 'DEVICE', 'otherNames': ['C-Port® Distal Anastomosis System', 'C-Port® xA™ Distal Anastomosis System', 'C-Port® FlexA™ Distal Anastomosis System', 'C-Port® XCHANGE™ Distal Anastomosis System'], 'description': 'creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures', 'armGroupLabels': ['anastomoses in blood vessels and grafts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Genesis Medical Center', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44307', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Akron General Medical Center', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiopulmonary Research Science & Technology Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53226', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin Heart', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'overallOfficials': [{'name': 'Husam Balkhy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wisconsin Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardica, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}