Angiography Versus (vs) IVUS Optimisation (AVIO)

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Status

Completed

Conditions

Myocardial Infarction

Treatments

Procedure: IVUS optimised DES implantation

Procedure: angiographically guided DES implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00936169

AVIO

Details and patient eligibility

About

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

Enrollment

284 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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