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. Identifier: NCT00714623
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : December 24, 2012
Cordis Corporation
Information provided by (Responsible Party):
Paul S Teirstein, MD, Scripps Clinic

Brief Summary:

This study is a prospective, non-randomized, open-label registry of consecutive patients with CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts will be included in the registry. The registry is conducted for the evaluation of the impact of CypherTM Sirolimus-eluting stent implantation in the "real world" of interventional cardiology. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study specific procedures. Consecutive patients treated with the use of the CypherTM stent will be included in the registry. Baseline and post-procedure blood samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA (Rapid Platelet Function Assay).

All patients will be followed from enrollment through the hospital discharge for any clinically significant event (death, myocardial infarction, TLR, TVR, major or minor bleeding). A follow-up telephone assessment of death, myocardial infarction, revascularization, and medical treatment will be conducted by experienced research personnel at 30 days, 6 months, 1 year and at least 2 years. All site reported deaths, myocardial infarctions and revascularizations will be adjudicated by an independent Clinical Events Committee for all 1000 patients enrolled in the trial. An interim analysis of the first 750 patients will be conducted and data forwarded to FDA.

Condition or disease Intervention/treatment
Coronary Artery Disease Coronary Restenosis Coronary Thrombosis Device: Sirolimus-Eluting Bx Velocity Coronary Stent (CypherTM Sirolimus-Eluting Stent)

Study Type : Observational
Actual Enrollment : 859 participants
Time Perspective: Prospective
Official Title: A Prospective Registry for the Use of CypherTM Sirolimus-Eluting Stents In Patients With Coronary Artery Disease Treated With Percutaneous Coronary Interventions at Scripps Clinic
Study Start Date : March 2005
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: Sirolimus-Eluting Bx Velocity Coronary Stent (CypherTM Sirolimus-Eluting Stent)
    Indications for use: The CYPHER™ Sirolimus-eluting Coronary Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length less than or equal to 30 mm in native coronary arteries with a reference vessel diameter between 2.5 and 3.5 mm. Long-term outcome (beyond 12 months) for this permanent implant is unknown at present.
    Other Name: CYPHER™ Stent

Primary Outcome Measures :
  1. 1 yr target vessel failure (TVF), defined as the occurrence of any of the following within 1-year after the index procedure: death from cardiac causes, Q-wave or non-Q wave MI attributable to the target vessel (TV), or revascularization of the TV. [ Time Frame: 1 year ]

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:   Probability Sample
Study Population
Patients 18 years of age or older undergoing PCI and requiring the placement of at least one drug-eluting stent will be included to this study. For this registry, consecutive patients, that will have coronary percutaneous intervention with the CypherTM at the Green Hospital of Scripps Clinic, will be enrolled. It is estimated that up to 1000 patients will be included in the registry enrolled over a four year period. It is expected that enrollment will conclude in March 2009.

Inclusion Criteria:

  1. Age 18 years or older
  2. Eligible for percutaneous coronary intervention
  3. Patient has at least one lesion ≥50% diameter stenosis requiring PCI with stenting
  4. Reference vessel diameter 2.25-4.0 mm
  5. Percutaneous intervention with use of one or more of the FDA approved CypherTM stents, planned not to exceed 108 mm of stent length.
  6. Target lesion is located within a native coronary artery or bypass graft
  7. De novo and restenotic lesions, including ISR, radiation failure
  8. Be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up
  9. Able to understand and grant informed consent

Exclusion Criteria:

  1. Confirmed pregnancy at the time of index PCI
  2. Has known allergies to aspirin, and to both clopidogrel (PlavixTM) and ticlopidine (TiclidTM)
  3. Has known allergies or contraindication to heparin and Bivalirudin (AngiomaxTM)
  4. Known allergy or sensitivity to any component of a Sirolimus-eluting stent
  5. Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
  6. Any serious disease condition with life expectancy of less than 1 year.

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 identifier (NCT number): NCT00714623

United States, California
Scripps Green Hospital/Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
Sponsors and Collaborators
Paul S Teirstein, MD
Cordis Corporation
Principal Investigator: Paul S Teirstein, MD Scripps Clinic

Responsible Party: Paul S Teirstein, MD, Chief of Cardiology, Scripps Clinic Identifier: NCT00714623     History of Changes
Other Study ID Numbers: 04-048
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by Paul S Teirstein, MD, Scripps Clinic:
Coronary Artery Disease
Coronary Restenosis
Coronary Thrombosis
Drug-Eluting Stents
Angioplasty, Transluminal, Percutaneous Coronary

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Coronary Thrombosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Coronary Stenosis
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs