Coronary Artery Disease Clinical Trial
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
Verified date | December 2012 |
Source | Scripps Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 859 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Scripps Green Hospital/Scripps Clinic Torrey Pines | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Paul S Teirstein, MD | Cordis Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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