Status:
UNKNOWN
Optical Coherence Tomography for Drug Eluting Stent Safety
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Collaborating Sponsors:
Case Western Reserve University
Medtronic Vascular
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at s...
Detailed Description
If overlapping drug-eluting stents provide increased vessel toxicity is not known. Given the association of delayed healing and incomplete endothelialization observed in animal and human autopsy studi...
Eligibility Criteria
Inclusion
- Native coronary artery disease with ≥ 75% diameter stenosis
- Lesion length ≥ 20 mm,
- Vessel size in between 2.5 and 3.5 mm.
- Multiple, overlapped DES vs BMS placement (intention to overlap ≥ 4 mm)
- Signed patient informed consent
Exclusion
- left main coronary artery disease,
- lesions in coronary artery bypass grafts,
- acute myocardial infarction,
- poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
- allergy to aspirin and or clopidogrel/ticlo,
- renal failure with creatinine value \> 2.5,
- no suitable anatomy for OCT scan
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00693030
Start Date
August 1 2006
End Date
December 1 2008
Last Update
June 6 2008
Active Locations (1)
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1
Cardiovascular Department Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100