Status:
COMPLETED
Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Collaborating Sponsors:
Case Western Reserve University
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte stent implantati...
Detailed Description
Major concerns were addressed to the delayed healing process of drug-eluting stents in off-label indications. To date no studies have detailed the in-vivo completeness of DES coverage at different tim...
Eligibility Criteria
Inclusion
- Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents
- Native coronary artery disease with \>= 75% diameter stenosis
- Vessel size in between 2.5 and 3.5 mm.
- Written informed consent signed
Exclusion
- No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter).
- significant left main coronary artery disease,
- lesions in bypass grafts,
- acute myocardial infarction,
- poor cardiac function as defined by left ventricular ejection fraction ≤ 30%.
- allergy to aspirin and or clopidogrel/ticlopidine,
- Renal failure with creatinine value \> 2.5 mg/dl
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00704145
Start Date
November 1 2007
End Date
November 1 2009
Last Update
February 9 2010
Active Locations (1)
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1
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100