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To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® 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 delivery system
Firebird2® sirolimus eluting stent system
Sponsored by
Beijing AmsinoMed Medical Device Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AVI® Arsenic trioxide drug eluting stent

Firebird2® sirolimus eluting stent system

Arm Description

Study group: Arsenic trioxide drug eluting stent delivery system (AVI®)

Control group: sirolimus eluting cobalt-chromium alloy stent system(Firebird 2®)

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

First Posted
May 6, 2014
Last Updated
November 14, 2019
Sponsor
Beijing AmsinoMed Medical Device Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02133287
Brief Title
To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
Official Title
A Prospective, Multi-center, Randomized Trial To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
November 2022 (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
To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.
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.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AVI® Arsenic trioxide drug eluting stent
Arm Type
Experimental
Arm Description
Study group: Arsenic trioxide drug eluting stent delivery system (AVI®)
Arm Title
Firebird2® sirolimus eluting stent system
Arm Type
Active Comparator
Arm Description
Control group: sirolimus eluting cobalt-chromium alloy stent system(Firebird 2®)
Intervention Type
Device
Intervention Name(s)
AVI® Arsenic trioxide drug eluting stent delivery system
Intervention Type
Device
Intervention Name(s)
Firebird2® sirolimus eluting stent system
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
80 Years
Accepts Healthy Volunteers
No
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 diameter stenosis(DS) ≥70％, reference vessel diameter between ≥2.5mm, and ≤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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Huo, Prof.
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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