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

A Prospective, Multi-center, Randomized Trial To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization

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

Study Overview

• Status: Unknown
• Conditions: Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Ischemic Heart Disease
• Intervention / Treatment: Device: AVI® Arsenic trioxide drug eluting stent delivery system; Device: Firebird2® sirolimus eluting stent system

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVI® Arsenic trioxide drug eluting stent; Study group: Arsenic trioxide drug eluting stent delivery system (AVI®)	Device: AVI® Arsenic trioxide drug eluting stent delivery system
Active Comparator: Firebird2® sirolimus eluting stent system; Control group: sirolimus eluting cobalt-chromium alloy stent system(Firebird 2®)	Device: Firebird2® sirolimus eluting stent system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	at 12 months post procedure

Collaborators and Investigators

• Sponsor: Beijing AmsinoMed Medical Device Co., Ltd
• Investigators: Principal Investigator: Yong Huo, Prof., Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): June 1, 2018
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 8, 2014

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Acute Coronary Syndrome; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Arsenic Trioxide; Sirolimus
• Other Study ID Numbers: PERFECT-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO