Spot Drug-Eluting Stenting for Long Coronary Stenoses
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Purpose
Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents. The investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very tight parts of the coronary narrowing, might result in better outcomes by means of avoiding multiple stents that have been associated with significant complications such as late stent thrombosis.
| Condition | Intervention |
|---|---|
|
Angioplasty |
Device: Drug-eluting stents (Cypher and Taxus) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Spot Drug-Eluting vs Full Cover Stenting for Long Coronary Stenoses: a Randomized Clinical Study |
- Major adverse cardiac events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 179 |
| Study Start Date: | January 2003 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Full cover stenting of coronary lesions
|
Device: Drug-eluting stents (Cypher and Taxus)
Spot or full length stenting of a coronary lesion
Other Names:
|
|
Active Comparator: 2
Spot-stenting of significantly stenotic parts of a coronary lesion
|
Device: Drug-eluting stents (Cypher and Taxus)
Spot or full length stenting of a coronary lesion
Other Names:
|
Detailed Description:
Coronary artery lesion length is an independent predictor of restenosis following coronary intervention and the deployment of multiple or long bare metal stents has been associated with an increased risk of adverse clinical outcome. Spot stenting, ie discrete stenting of only the most severe stenoses of long, diffuse lesions has been proposed as an alternative in this clinical setting. The introduction of drug-eluting stents has resulted in longer lesions being stented and the use of multiple, overlapping DES in patients with diffusely diseased coronary arteries has been considered safe and effective. However, there has also been evidence of increased major adverse cardiac events (MACE) with the use of multiple, overlapping DES,10-12 while long DES have been associated with increased probability of intraprocedural stent thrombosis.13 We hypothesized that an approach based on spot-stenting with the use of DES might result in superior clinical outcomes compared to full cover of atheromatic lesions with long or multiple stents. We are therefore conducting a randomized comparison of spot versus multiple overlapping stenting on consecutive patients with long (>20 mm) lesions and indications for percutaneous coronary intervention.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.
Exclusion Criteria:
- Unprotected left main coronary artery stenosis,
- Left ventricular ejection fraction <25%, OR
- Contraindication to aspirin or clopidogrel
Contacts and Locations| Greece | |
| Athens Euroclinic | |
| Athens, Attica, Greece, 11521 | |
| Athens Euroclinic | |
| Athens, Greece | |
| Study Chair: | Demosthenes Katritsis, MD, PhD | Athens Euroclinic and Cardiovasdcular Research Society |
More Information
Publications:
| Responsible Party: | Department of Cardiology, Athens Euroclinic |
| ClinicalTrials.gov Identifier: | NCT00738556 History of Changes |
| Other Study ID Numbers: | 2.15.8.08 |
| Study First Received: | August 18, 2008 |
| Last Updated: | January 28, 2009 |
| Health Authority: | Greece: Ethics Committee |
Additional relevant MeSH terms:
|
Coronary Stenosis Coronary Disease Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013