Spot Drug-Eluting Stenting for Long Coronary Stenoses

January 28, 2009 updated by: Cardiovascular Research Society, Greece

Spot Drug-Eluting vs Full Cover Stenting for Long Coronary Stenoses: a Randomized Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Athens Euroclinic
    • Attica
      • Athens, Attica, Greece, 11521
        • Athens Euroclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac events
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular Research Society, Greece

Investigators

  • Study Chair: Demosthenes Katritsis, MD, PhD, Athens Euroclinic and Cardiovasdcular Research Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.15.8.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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