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

Cordis US Corp.1,500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Coronary Stenosis

Interventions

CYPHER® Bx Velocity™ stent (sirolimus-eluting)DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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