Status:
COMPLETED
The SCRIPPS DES REAL WORLD Registry
Lead Sponsor:
Paul S Teirstein, MD
Collaborating Sponsors:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Coronary Restenosis
Eligibility:
All Genders
18+ years
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
859 Patients enrolled
Trial Details
Trial ID
NCT00714623
Start Date
March 1 2005
End Date
April 1 2012
Last Update
December 24 2012
Active Locations (1)
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1
Scripps Green Hospital/Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037