To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization

Beijing AmsinoMed Medical Device

Status: Unknown

Conditions: Ischemic Heart Disease; Myocardial Ischemia; Acute Coronary Syndrome; Coronary Disease

Treatments: Device: AVI® Arsenic trioxide drug eluting stent delivery system; Device: Firebird2® sirolimus eluting stent system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02133287

PERFECT-II

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,000 participants in 2 patient groups

AVI® Arsenic trioxide drug eluting stent

Experimental group

Description:

Study group: Arsenic trioxide drug eluting stent delivery system (AVI®)

Treatment:

Device: AVI® Arsenic trioxide drug eluting stent delivery system

Firebird2® sirolimus eluting stent system

Active Comparator group

Description:

Control group: sirolimus eluting cobalt-chromium alloy stent system(Firebird 2®)

Treatment:

Device: Firebird2® sirolimus eluting stent system