The SCRIPPS DES REAL WORLD Registry

This study has been completed.
Sponsor:
Collaborator:
Cordis Corporation
Information provided by (Responsible Party):
Paul S Teirstein, MD, Scripps Clinic
ClinicalTrials.gov Identifier:
NCT00714623
First received: July 9, 2008
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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 Intervention
Coronary Artery Disease
Coronary Restenosis
Coronary Thrombosis
Device: Sirolimus-Eluting Bx Velocity Coronary Stent (CypherTM Sirolimus-Eluting Stent)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Scripps Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 859
Study Start Date: March 2005
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714623

Locations
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
Investigators
Principal Investigator: Paul S Teirstein, MD Scripps Clinic
  More Information

No publications provided

Responsible Party: Paul S Teirstein, MD, Chief of Cardiology, Scripps Clinic
ClinicalTrials.gov Identifier: NCT00714623     History of Changes
Other Study ID Numbers: 04-048
Study First Received: July 9, 2008
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Scripps Health:
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 Thrombosis
Thrombosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Coronary Stenosis
Sirolimus
Everolimus
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 July 23, 2014