Angiography Versus (vs) IVUS Optimisation

NCT ID: NCT00936169

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-07-31

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

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVUS optimised stent implantation

Group Type: EXPERIMENTAL

IVUS optimised DES implantation

Intervention Type: PROCEDURE

Ivus optimised stent implantation

angiographically guided DES implantation

Group Type: ACTIVE_COMPARATOR

angiographically guided DES implantation

Intervention Type: PROCEDURE

angiographically guided DES implantation

Interventions

IVUS optimised DES implantation

Ivus optimised stent implantation

Intervention Type: PROCEDURE

angiographically guided DES implantation

angiographically guided DES implantation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mediolanum Cardio Research

OTHER

Sponsor Role: collaborator

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Chieffo A, Latib A, Caussin C, Presbitero P, Galli S, Menozzi A, Varbella F, Mauri F, Valgimigli M, Arampatzis C, Sabate M, Erglis A, Reimers B, Airoldi F, Laine M, Palop RL, Mikhail G, Maccarthy P, Romeo F, Colombo A. A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial. Am Heart J. 2013 Jan;165(1):65-72. doi: 10.1016/j.ahj.2012.09.017. Epub 2012 Nov 20.

Reference Type: DERIVED

PMID: 23237135 (View on PubMed)

Other Identifiers

AVIO

Identifier Type: -

Identifier Source: org_study_id