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

Acute Coronary Syndrome Clinical Trial

Official title:

A Prospective, Multi-center, Randomized Trial To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02133287
• Other study ID #: PERFECT-II
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2013
• Est. completion date: November 2022

Study information

• Verified date: November 2019
• Source: Beijing AmsinoMed Medical Device Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: November 2022
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• AVI® Arsenic trioxide drug eluting stent delivery system

• Firebird2® sirolimus eluting stent system

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing AmsinoMed Medical Device Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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