Status:
COMPLETED
Prospective Study to Assess DES Re-endothelization in BMS Restenosis and De-novo Lesions
Lead Sponsor:
S.M. Misericordia Hospital
Conditions:
Stable Coronary Artery Disease
Silent Myocardial Ischemia
Eligibility:
All Genders
18-90 years
Brief Summary
The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two d...
Eligibility Criteria
Inclusion
- Patients suitable for implantation of everolimus-eluting stents (Xcience V, Xience Prime) because of stable/unstable angina or silent myocardial ischemia due to:
- Group A: single BMS restenosis (\> 50% of luminal diameter)
- Group B: single de-novo lesion (\> 50% of luminal diameter)
Exclusion
- contraindications to dual antiplatelet therapy
- acute myocardial infarction within the previous 48 hours
- significant left main coronary artery disease
- reference vessel diameter \< 2.5 mm,
- hemodynamic instability
- chronic kidney disease with serum creatinine \> 2 mg/dl
- pregnancy
- allergy to contrast agent, everolimus, aspirin, clopidogrel
- life expectancy \< 24 months
- patients with possible low adherence to medical therapy
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01243099
Start Date
November 1 2010
End Date
July 1 2013
Last Update
July 23 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Misericordia Hospital
Grosseto, Italy, 58100