The Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent (S.T.L.L.R.)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-04-30

Brief Summary

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1500 eligible patients will be treated with the commercially available CYPHER® sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months post-procedure, watching for patients that require a repeat procedure on the same diseased area of the coronary artery.

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Detailed Description

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Geographical miss has been associated with treatment failures after intracoronary radiation therapy. This phenomenon, which is secondary to vascular injury outside the treated segment, was strongly correlated with the development of restenosis at the edges of the treated coronary segment. The European and Canadian SIRIUS trials (E and C-SIRIUS) randomized 350 patients with similar baseline characteristics of the US SIRIUS study. Operators used shorter post-dilatation balloons and direct stented 27% of the patients, achieving a 4.0% TLR rate and a 5.1% in-lesion binary restenosis. These somewhat superior results support the concept that refinement in deployment techniques may further improve clinical outcomes of drug-eluting stents.

Conditions

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Coronary Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CYPHER® Bx Velocity™ stent (sirolimus-eluting)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of de novo stenosis in major coronary artery
* Can be treated with stents
* Candidate for bypass

Exclusion Criteria

* Recent, severe MI
* Prior brachytherapy
* Impaired left ventricle function
* Heart transplant recipient
* Impaired renal function
* Disease in vein grafts from previous bypass
* Similar treatment within the last 30 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No