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

Prospective Evaluation of the Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent, The e-CYPHER(SM)S.T.L.L.R., Registry [Study of Deployment Technique on Clinical Results]

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00403338

Enrollment

1500

Registered

2006-11-23

Start date

2004-12-31

Completion date

2006-04-30

Last updated

2009-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Stenosis

Keywords

myocardial ischemia, coronary disease, heart disease, Coronary Stenosis [MeSH heading: C14.280.647.250.285]

Brief summary

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.

Detailed 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.

Interventions

DEVICECYPHER® Bx Velocity™ stent (sirolimus-eluting)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026