Phase
Condition
Myocardial Ischemia
Heart Defect
Cardiac Disease
Treatment
N/AClinical Study ID
Ages 18-76 All Genders
Study Summary
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
Study Description
Connect with a study center
The First Teaching Hospital of Xinjiang Medical University
Urumqi, Xinjiang 830054
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.