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

Cordis

Status: Completed

Conditions: Coronary Stenosis

Treatments: Device: CYPHER® Bx Velocity™ stent (sirolimus-eluting)

Study type: Observational

Funder types: Industry

Identifiers

NCT00403338

P03-6323

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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