Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-20 @ 3:32 PM
Study NCT ID:
NCT00618020
Status:
COMPLETED
Last Update Posted:
2008-07-18
First Post:
2008-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054059', 'term': 'Coronary Occlusion'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-17', 'studyFirstSubmitDate': '2008-01-28', 'studyFirstSubmitQcDate': '2008-02-05', 'lastUpdatePostDateStruct': {'date': '2008-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications.', 'timeFrame': 'during procedure, 1day, 1week and 30 days post procedure'}], 'secondaryOutcomes': [{'measure': 'Successful stenting', 'timeFrame': 'During procedure, Day1, Day7 and Day30 post procedure'}, {'measure': 'Wire crossing duration', 'timeFrame': 'during procedure'}, {'measure': 'Fluoroscopy time', 'timeFrame': 'during procedure'}, {'measure': 'Amount of contrast', 'timeFrame': 'during procedure'}, {'measure': 'Maneuverability of the CiTop™ up to the occlusion', 'timeFrame': 'during procedure'}, {'measure': 'No mechanical damage to the device during', 'timeFrame': 'during procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CTO', 'Chronic Total Occlusion', 'Revascularization'], 'conditions': ['Coronary Occlusion']}, 'descriptionModule': {'briefSummary': 'The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent obtained prior to any trial activities.\n2. Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).\n3. Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.\n\nExclusion Criteria:\n\n1. Patient unable to give informed consent.\n2. Current participation in another study with any investigational drug or device.\n3. Factors making follow-up and/or repeat angiography difficult or unlikely.\n4. Contra-indication to emergency artery by pass surgery.\n5. Lack of surgical backup.\n6. Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.\n7. Lesion \\> 40mm in length (both calcified lesion and adjacent thrombus).\n8. Treated vessel referenced diameter less than 2.5 mm.\n9. Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.\n10. Non-visible entry point of target lesion.\n11. Totally occluded bypass graft as target vessel.\n12. Acute MI less than 1 week before procedure.\n13. Patient has significant LV dysfunction, 35% LVEF or less.\n14. Patient with cancer or other sever chronic disease with life expectance of 2 years.\n15. Patient has chronic renal failure with serum creatinine ≥2.\n16. Hemoglobin ≤11.\n17. Patient is known or suspected not to tolerate the contrast agent.\n18. Morbid Obesity (BMI \\> 40).\n19. Drug abuse or alcoholism.\n20. Patients under custodial care.\n21. Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.'}, 'identificationModule': {'nctId': 'NCT00618020', 'briefTitle': 'Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ovalum'}, 'officialTitle': 'A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries', 'orgStudyIdInfo': {'id': '4C-b No. OVC-C01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CiTop(tm) Guidewire', 'type': 'DEVICE', 'description': 'CiTop(tm)6 Guidewire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '380054', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'S.A.L Hospital', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}], 'overallOfficials': [{'name': 'Keyur Parikh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chairman,CardioVascular Services,SAL Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ovalum', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Affairs', 'oldOrganization': 'Ovalum Ltd.'}}}}