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Completed

NCT Number: NCT00738556

Spot Drug-Eluting Stenting for Long Coronary Stenoses

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athens Euroclinic, Athens, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug-eluting stents (Cypher and Taxus)

Device

Spot or full length stenting of a coronary lesion

Other names: Sirolimus-eluting stents (Cypher, J&J), Paclitaxel-eluting stents (Taxus, Boston Scientific)

Primary outcomes

  1. Major adverse cardiac events

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Cardiovascular Research Society, Greece

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Aug 20, 2008
Registry last updated
Jan 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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