Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
This study has been completed.
Sponsor:
Rigshospitalet, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00151658
First received: September 8, 2005
Last updated: September 12, 2005
Last verified: September 2005
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ischaemic Heart Disease |
Device: Coronary Drug Eluting Stents for PCI |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent |
Resource links provided by NLM:
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Minimal lumen diameter
- Frequency of restenosis (>50%) at 6 months.
Secondary Outcome Measures:
- Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months
| Estimated Enrollment: | 322 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | June 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Stable, 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.
Complex lesions to be included should have at least one of the following characteristics:
- Ostial in location (< 5 mm from ostium)
- Total occlusions with a length ≥ 15 mm
- Bifurcational (side branch > 1.75 mm in diameter)
- Angulated (> 45° within lesion)
Exclusion Criteria:
Patients:
- Other severe disease with an expected survival < 1 year
- Other significant cardiac disease
- Known allergy against paclitaxel, clopidogrel or stainless steel.
- Myocardial infarction within 3 days of the index procedure
- Linguistic difficulties needing an interpreter
- Renal insufficiency (p-creatinine > 200 micromol/l)
- Gastrointestinal bleeding within 1 month
- Childbearing potential or pregnancy
- Participation in another study
Lesions:
- Unprotected left main disease
- Restenosis
- Lesions containing visible thrombus
- Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
- Diffuse coronary disease distal to the treated lesion
- Heavily calcification
- Lesion located in saphenous vein graft
Contacts and Locations More Information
No publications provided by Rigshospitalet, Denmark
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00151658 History of Changes |
| Other Study ID Numbers: | SCANDSTENT |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Rigshospitalet, Denmark:
|
Coronary complex lesions Restenosis Drug eluting stents |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on October 16, 2012
