Clinical trial NCT02133287: To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
Official title: A Prospective, Multi-center, Randomized Trial To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Lead sponsor: Beijing AmsinoMed Medical Device Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-05-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.

Detailed description: The study is a Prospective, Open-lable, Multi-center, Randomized trial. 2000 primary coronary artery disease patients will be enrolled with a 1:1 randomization ratio(AVI:1000,Firebird 2:1000) at approximately 40 sites, Subject follow-up be at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.

Eligibility criteria: Inclusion Criteria:

1. Patient must be at least 18 years of age.
2. Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI)
3. At least one lesion diameter stenosis(DS) ≥70％, reference vessel diameter between ≥2.5mm, and ≤3.5mm.
4. 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 stent must be the same brand stent as the index procedure.
5. Subject has no CABG contraindication.
6. Subject or legal representative is informed the property of the study, understand the stipulations in the protocol, ensure the compliance and sign the ICF.

Exclusion Criteria:

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

Primary outcomes:
measure: Ischemia-driven target lesion failure(iTLF), including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)
timeFrame: at 12 months post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo, Prof.
role: PRINCIPAL_INVESTIGATOR
References: