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

Primary Purpose

Ischemic Heart Disease, Myocardial Ischemia, Coronary Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

AVI® Arsenic trioxide drug eluting stent

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Teaching Hospital of Xinjiang Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVI® Arsenic trioxide drug eluting stent

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT02117843

First Posted

April 16, 2014

Last Updated

June 24, 2017

Sponsor

Beijing AmsinoMed Medical Device Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02117843

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing AmsinoMed Medical Device Co., Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AVI® Arsenic trioxide drug eluting stent

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

AVI® Arsenic trioxide drug eluting stent

Intervention Description

AVI® Arsenic trioxide drug eluting stent

Primary Outcome Measure Information:

Title

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)

Time Frame

at 12 months post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

76 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yitong Ma, Prof.

Phone

86-0991-4362611

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yitong Ma, Prof.

Organizational Affiliation

First Affiliated Hospital of Xinjiang Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Teaching Hospital of Xinjiang Medical University

City

Urumqi

State/Province

Xinjiang

ZIP/Postal Code

830054

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yitong Ma, Prof.

Phone

86-0991-4362611

12. IPD Sharing Statement

Plan to Share IPD

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

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