Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01204320
Status:
TERMINATED
Last Update Posted:
2010-09-17
First Post:
2010-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'lastUpdateSubmitDate': '2010-09-16', 'studyFirstSubmitDate': '2010-09-16', 'studyFirstSubmitQcDate': '2010-09-16', 'lastUpdatePostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Binary restenosis defined as >50% diameter stenosis by QCA', 'timeFrame': '6 months'}, {'measure': 'Major Adverse Cardiac Events', 'timeFrame': '6, 12 months'}, {'measure': 'Target Lesion Revascularization', 'timeFrame': '6, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Restenosis', 'POBA', 'Stenting', 'Paclitaxel'], 'conditions': ['Stable Angina', 'Unstable Angina']}, 'descriptionModule': {'briefSummary': 'This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.', 'detailedDescription': 'The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* \\>18y\n* Stable Angina or Unstable Angina\n* Single restenotic lesion in a previously stented coronary artery\n\nExclusion Criteria:\n\n* Acute Myocardial Infarction within 72h\n* Serum Creatinine\\>2.0 mg/dL\n* Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel\n* Contraindications to contrast media\n* Life expectancy \\< 2y\n* Target Lesion length \\> 30mm\n* Target Lesion diameter \\<= 2.5 mm\n* Target stenosis \\< 70%\n* Massive Calcifications in the target segment\n* Evidence of intra-coronary thrombus'}, 'identificationModule': {'nctId': 'NCT01204320', 'acronym': 'COMPACT-ISR', 'briefTitle': 'A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Donato'}, 'orgStudyIdInfo': {'id': 'Arezzo003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel-coated Balloon', 'description': 'Paclitaxel-coated Balloon Angioplasty', 'interventionNames': ['Procedure: Paclitaxel-coated Balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel-eluting Stent', 'description': 'Paclitaxel-eluting Stent Implantation', 'interventionNames': ['Device: Paclitaxel-eluting Stent']}], 'interventions': [{'name': 'Paclitaxel-coated Balloon', 'type': 'PROCEDURE', 'otherNames': ['Orbus'], 'description': 'POBA', 'armGroupLabels': ['Paclitaxel-coated Balloon']}, {'name': 'Paclitaxel-eluting Stent', 'type': 'DEVICE', 'otherNames': ['Taxus'], 'description': 'Stenting', 'armGroupLabels': ['Paclitaxel-eluting Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52100', 'city': 'Arezzo', 'state': 'AR', 'country': 'Italy', 'facility': 'San Donato Hospital', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}], 'overallOfficials': [{'name': 'Leonardo Bolognese, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiovascular Department - San Donato Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Donato', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cardiovascular Department USL 8(Leonardo Bolognese MD)', 'oldOrganization': 'Ospedale SanDonato'}}}}