The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization

Not Applicable

• Conditions: Ischemic Heart Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome
• Interventions: Device: AVI® Arsenic trioxide drug eluting stent

• Registration Number: NCT02117843
• Lead Sponsor: Beijing AmsinoMed Medical Device Co., Ltd

Brief Summary

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization.

Detailed Description

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization, 1200 primary coronary artery disease patients will be enrolled, at approximately 40 sites. Subject follow-up will occur via telephone contact or clinical visit at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-24
• Last Update Posted: 2017-06-27
• Primary Completion: 2017-12
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Patient must be at least 18 years of age;

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);

At least one lesion with a diameter stenosis >70% or more suitable for coronary stent implantation 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 stent must 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 the stipulations in the protocol, ensure the compliance and sign the ICF;

Exclusion Criteria

Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure;

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;

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 and contrast 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 and Firebird 2 stents;

The subject attended other drug/device study or in the follow-up period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AVI® Arsenic trioxide drug eluting stent	AVI® Arsenic trioxide drug eluting stent	The Arsenic trioxide as AVI eluting drug, biodegradable polylactic acid as drug carrier.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Teaching Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China