The SCRIPPS DES REAL WORLD Registry

Sponsor

Paul S Teirstein, MD (Other)

Overall Status

Completed

CT.gov ID

NCT00714623

Collaborator

Cordis Corporation (Industry)

859

Enrollment

Location

Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

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 :

Mar 1, 2005

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Outcome Measures

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. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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