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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00403338
First received: November 22, 2006
Last updated: October 5, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Stenosis
 Device: CYPHER® Bx Velocity™ stent (sirolimus-eluting)
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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]

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Enrollment: 1500
Study Start Date: December 2004
Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients needing an intervention and receiving a CYPHER stent.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403338

Sponsors and Collaborators
Cordis Corporation
Investigators
Study Director: Amy Orlick Cordis Corporation, a Johnson & Johnson Co.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00403338     History of Changes
Other Study ID Numbers: P03-6323
Study First Received: November 22, 2006
Last Updated: October 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Cordis Corporation:
myocardial ischemia
coronary disease
heart disease
Coronary Stenosis [MeSH heading: C14.280.647.250.285]

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013