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OpenTrials
Completed

NCT Number: NCT00403338

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

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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Key information

Conditions

Coronary Stenosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CYPHER® Bx Velocity™ stent (sirolimus-eluting)

Device

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study title

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]

Important dates

Study start
2004
Study completion
2006
First posted
Nov 23, 2006
Registry last updated
Oct 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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