Status:
COMPLETED
Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Collaborating Sponsors:
Case Western Reserve University
Medtronic
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent v...
Detailed Description
Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that...
Eligibility Criteria
Inclusion
- Acute Myocardial MI with ST segment Elevation, within 12 hours from symptoms onset
- Native coronary artery disease with \>70% diameter stenosis (no prior stent implant, no prior brachytherapy)
- Vessel size in between 2.5 and 3.75 mm
- Signed patient informed consent
Exclusion
- Lesions in coronary artery bypass grafts
- Significant left main disease
- Killip class IV
- Reecent major bleeding (6 months)
- Renal failure with creatinine value \> 2.5 mg/dl
- Allergy to aspirin and or clopidogrel/ticlopidine
- Patient in anticoagulant therapy
- IMA due to a stent thrombosis
- No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels \[≥ 3.75 mm in diameter\])
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00704561
Start Date
April 1 2008
End Date
October 1 2009
Last Update
May 23 2022
Active Locations (1)
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1
Ospedali Riuniti di Bergamo
Bergamo, Italy