Clinical Trials Directory

Trials / Completed

CompletedNCT00738556

Spot Drug-Eluting Stenting for Long Coronary Stenoses

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
179 (actual)
Sponsor
Cardiovascular Research Society, Greece · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
DEVICEDrug-eluting stents (Cypher and Taxus)Spot or full length stenting of a coronary lesion

Timeline

Start date
2003-01-01
Primary completion
2007-09-01
Completion
2007-09-01
First posted
2008-08-20
Last updated
2009-01-29

Locations

2 sites across 1 country: Greece

Source: ClinicalTrials.gov record NCT00738556. Inclusion in this directory is not an endorsement.