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

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

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

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 Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • Recruiting
      • The First Teaching Hospital of Xinjiang Medical University
      • Contact: Yitong Ma, Prof.; Phone Number: 86-0991-4362611

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVI® Arsenic trioxide drug eluting stent; The Arsenic trioxide as AVI eluting drug, biodegradable polylactic acid as drug carrier.	Device: AVI® Arsenic trioxide drug eluting stent; AVI® Arsenic trioxide drug eluting stent

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: Yitong Ma, Prof., First Affiliated Hospital of Xinjiang Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 16, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 24, 2017
• Last Verified: June 1, 2017

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; Antineoplastic Agents; Arsenic Trioxide
• Other Study ID Numbers: PERFECT-I

Plan for Individual participant data (IPD)

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