Status:
COMPLETED
Angiography Versus (vs) IVUS Optimisation
Lead Sponsor:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Collaborating Sponsors:
Mediolanum Cardio Research
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions
Eligibility Criteria
Inclusion
- A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion
Exclusion
- Contra-indication to dual anti-platelet therapy.
- Ejection fraction \<30%.
- Renal failure (creatinine \>2 mg/dL).
- Significant co-morbidity precluding clinical follow-up.
- Acute myocardial infarction in the 48 hours prior to the procedure.
- In-stent restenosis
- Prior brachytherapy
- Thrombocytopenia \<100,000
- Unprotected left main stem stenosis
- Venous or arterial grafts
- Recipient of heart transplant
- A positive pregnancy test in women with child bearing potential
- Acute infections
- Major surgery planned which will lead to discontinuation of antiplatelet therapy
- Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event
- Age under 18 years old.
- There is no maximum number of lesions which can be treated
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT00936169
Start Date
May 1 2008
End Date
July 1 2011
Last Update
February 22 2012
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