To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
Study Details
Study Description
Brief Summary
To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AVI® Arsenic trioxide drug eluting stent Study group: Arsenic trioxide drug eluting stent delivery system (AVI®) |
Device: AVI® Arsenic trioxide drug eluting stent delivery system
|
| Active Comparator: Firebird2® sirolimus eluting stent system Control group: sirolimus eluting cobalt-chromium alloy stent system(Firebird 2®) |
Device: Firebird2® sirolimus eluting stent system
|
Outcome Measures
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) [at 12 months post procedure]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient must be at least 18 years of age.
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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)
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At least one lesion diameter stenosis(DS) ≥70％, reference vessel diameter between ≥2.5mm, and ≤3.5mm.
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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.
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Subject has no CABG contraindication.
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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:
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Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure.
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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.
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Poor compliance or expectation of life less than 1 year.
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Implanted any brand stent in the same target vessel within 1 year.
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Left Ventricular Ejection Fraction (LVEF) of <30％
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Cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support.
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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.
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Severe tortuous and/or heavy calcification lesion.
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Two or more proximal chronic total occlusion lesion.
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Bifurcation lesions with double stents.
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The subject has multi vessel lesions but can not be implanted the same brand stents
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The subject that the investigator considers he/she was unfit to implant the AVI stents and Firebird 2 stents.
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The subject attended other drug/device study or in the follow-up period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | Beijing | China | 100034 |
Sponsors and Collaborators
- Beijing AmsinoMed Medical Device Co., Ltd
Investigators
- Principal Investigator: Yong Huo, Prof., Peking University First Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PERFECT-II