Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00151658
Status:
COMPLETED
Last Update Posted:
2005-09-14
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2005-09-12', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimal lumen diameter'}, {'measure': 'Frequency of restenosis (>50%) at 6 months.'}], 'secondaryOutcomes': [{'measure': 'Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months'}]}, 'conditionsModule': {'keywords': ['Coronary complex lesions', 'Restenosis', 'Drug eluting stents'], 'conditions': ['Ischaemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '18498953', 'type': 'DERIVED', 'citation': 'Kelbaek H, Klovgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrom T, Botker HE, Jorgensen E, Saunamaki K, Aljabbari S, Thayssen P, Galloe A, Jensen GV, Thuesen L. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J Am Coll Cardiol. 2008 May 27;51(21):2011-6. doi: 10.1016/j.jacc.2008.01.056.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStable, or unstable angina and/or objective signs of myocardial ischaemia Lesions should be de novo and located in native vessels with a diameter \\> 2.25 mm.\n\nComplex lesions to be included should have at least one of the following characteristics:\n\n* Ostial in location (\\< 5 mm from ostium)\n* Total occlusions with a length ≥ 15 mm\n* Bifurcational (side branch \\> 1.75 mm in diameter)\n* Angulated (\\> 45° within lesion)\n\nExclusion Criteria:\n\nPatients:\n\n* Other severe disease with an expected survival \\< 1 year\n* Other significant cardiac disease\n* Known allergy against paclitaxel, clopidogrel or stainless steel.\n* Myocardial infarction within 3 days of the index procedure\n* Linguistic difficulties needing an interpreter\n* Renal insufficiency (p-creatinine \\> 200 micromol/l)\n* Gastrointestinal bleeding within 1 month\n* Childbearing potential or pregnancy\n* Participation in another study\n\nLesions:\n\n* Unprotected left main disease\n* Restenosis\n* Lesions containing visible thrombus\n* Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure\n* Diffuse coronary disease distal to the treated lesion\n* Heavily calcification\n* Lesion located in saphenous vein graft'}, 'identificationModule': {'nctId': 'NCT00151658', 'briefTitle': 'Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent', 'orgStudyIdInfo': {'id': 'SCANDSTENT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Coronary Drug Eluting Stents for PCI', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Henning Kelbaek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}