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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:
ClinicalTrials.gov Identifier:
NCT00403338
First Posted: November 23, 2006
Last Update Posted: October 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cordis Corporation
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 22, 2006
First Posted: November 23, 2006
Last Update Posted: October 7, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs