The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization

Last updated: June 24, 2017
Sponsor: Beijing AmsinoMed Medical Device Co., Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Heart Defect

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT02117843
PERFECT-I
  • Ages 18-76
  • All Genders

Study Summary

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patient must be at least 18 years of age; Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronaryartery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI); At least one lesion with a diameter stenosis >70% or more suitable for coronary stentimplantation in a vessel with a reference diameter ranging from 2.5mm to 3.5mm; If the subject has multiple vessel lesions, the implanted stents must be the same brand.The staged procedure only be allowed within 3 months after procedure, the implanted stentmust be the same brand stent as the index procedure; Subject has no CABG contraindication; Subject or legal representative is informed the property of the study, understand thestipulations in the protocol, ensure the compliance and sign the ICF;

Exclusion

Exclusion Criteria: Pregnant or nursing patients and those who plan to become pregnant up to 1 year post indexprocedure; Subject has a tendency to bleeding or coagulation disorders, or has contraindication ofantiplatelet and/or anticoagulant therapy, or can't accept the continue DAPT within 6months; Poor compliance or expectation of life less than 1 year; Implanted any brand stent in the same target vessel within 1 year; Left Ventricular Ejection Fraction (LVEF) of <30%; Cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support; The subject is allergic to asprin, heparin, clopidogrel/ticlopidine, stainless steel alloy,arsenic trioxide, sirolimus, styrene-butene-styrene or polylactic acid(PLA) polymer andcontrast agent; Severe tortuous and/or heavy calcification lesion; Two or more proximal chronic total occlusion lesion; Bifurcation lesions with double stents; The subject has multi-vessel lesions but can not be implanted the same brand stents; The subject that the investigator considers he/she was unfit to implant the AVI stents andFirebird 2 stents; The subject attended other drug/device study or in the follow-up period.

Study Design

Total Participants: 1200
Study Start date:
July 01, 2013
Estimated Completion Date:
April 30, 2021

Study Description

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization, 1200 primary coronary artery disease patients will be enrolled, at approximately 40 sites. Subject follow-up will occur via telephone contact or clinical visit at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.

Connect with a study center

  • The First Teaching Hospital of Xinjiang Medical University

    Urumqi, Xinjiang 830054
    China

    Active - Recruiting

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