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

NCT ID: NCT02133287

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2022-11-30

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.

Conditions

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

Study Design

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

Study Groups

AVI® Arsenic trioxide drug eluting stent

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

Group Type: EXPERIMENTAL

AVI® Arsenic trioxide drug eluting stent delivery system

Intervention Type: DEVICE

Firebird2® sirolimus eluting stent system

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

Group Type: ACTIVE_COMPARATOR

Firebird2® sirolimus eluting stent system

Intervention Type: DEVICE

Interventions

AVI® Arsenic trioxide drug eluting stent delivery system

Intervention Type: DEVICE

Firebird2® sirolimus eluting stent system

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing AmsinoMed Medical Device Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yong Huo, Prof.

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PERFECT-II

Identifier Type: -

Identifier Source: org_study_id