Spot Drug-Eluting Stenting for Long Coronary Stenoses

This study has been completed.
Sponsor:
Information provided by:
Cardiovascular Research Society, Greece
ClinicalTrials.gov Identifier:
NCT00738556
First received: August 18, 2008
Last updated: January 28, 2009
Last verified: January 2009
  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

Resource links provided by NLM:


Further study details as provided by Cardiovascular Research Society, Greece:

Primary Outcome Measures:
  • 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:
  • Sirolimus-eluting stents (Cypher, J&J)
  • Paclitaxel-eluting stents (Taxus, Boston Scientific)
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:
  • Sirolimus-eluting stents (Cypher, J&J)
  • Paclitaxel-eluting stents (Taxus, Boston Scientific)

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738556

Locations
Greece
Athens Euroclinic
Athens, Attica, Greece, 11521
Athens Euroclinic
Athens, Greece
Sponsors and Collaborators
Cardiovascular Research Society, Greece
Investigators
Study Chair: Demosthenes Katritsis, MD, PhD Athens Euroclinic and Cardiovasdcular Research Society