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

NCT02117843 | Unknown DMC

• 1 other identifier: PERFECT-I
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AVI® Arsenic trioxide drug eluting stent

EXPERIMENTAL

The Arsenic trioxide as AVI eluting drug, biodegradable polylactic acid as drug carrier.

Device: AVI® Arsenic trioxide drug eluting stent

Interventions

AVI® Arsenic trioxide drug eluting stent DEVICE

AVI® Arsenic trioxide drug eluting stent

AVI® Arsenic trioxide drug eluting stent

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing AmsinoMed Medical Device Co., Ltd: lead

Study Sites (1)

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yitong Ma, Prof.

  First Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yitong Ma, Prof.

CONTACT

86-0991-4362611

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2021
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)