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

NCT02133287 | Unknown DMC

• 1 other identifier: PERFECT-II
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® 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 (2)

AVI® Arsenic trioxide drug eluting stent

EXPERIMENTAL

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

Device: AVI® Arsenic trioxide drug eluting stent delivery system

Firebird2® sirolimus eluting stent system

ACTIVE COMPARATOR

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

Device: Firebird2® sirolimus eluting stent system

Interventions

AVI® Arsenic trioxide drug eluting stent delivery system DEVICE

AVI® Arsenic trioxide drug eluting stent

Firebird2® sirolimus eluting stent system DEVICE

Firebird2® sirolimus eluting stent system

Eligibility Criteria

• Age: 18 Years - 80 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 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.

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)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yong Huo, Prof.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 8, 2014
• Study Start: August 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2022
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)