Clinical trial NCT00714623: The SCRIPPS DES REAL WORLD Registry
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Restenosis
Coronary Thrombosis
Keywords: Coronary Artery Disease
Coronary Restenosis
Coronary Thrombosis
Drug-Eluting Stents
Angioplasty, Transluminal, Percutaneous Coronary
Lead sponsor: Scripps Health
Sponsor class: OTHER
Collaborators: name: Cordis Corporation
First posted: 2008-07-14
Enrollment: 859
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital/Scripps Clinic Torrey Pines
state: California
Study officials:
affiliation: Scripps Clinic
name: Paul S Teirstein, MD
role: PRINCIPAL_INVESTIGATOR
References: