To Evaluate The Safety and Efficacy of 'AVI' Stent Compar... | NCT02133287

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

NCT02133287

Sponsor

Beijing AmsinoMed Medical Device Co., Ltd

Status

Unknown status

Last Update Posted

Nov 15, 2019Actual

Enrollment

2,000Estimated

Phase

Not Applicable

Conditions

Ischemic Heart Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome

Interventions

AVI® Arsenic trioxide drug eluting stent delivery system
Firebird2® sirolimus eluting stent system

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013Actual

Primary Completion Date

Jun 2018Actual

Completion Date

Nov 2022Estimated

First Submitted Date

May 6, 2014

First Submission Date that Met QC Criteria

May 6, 2014

First Posted Date

May 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2019

Last Update Posted Date

Nov 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
AVI® Arsenic trioxide drug eluting stent delivery system	Device		AVI® Arsenic trioxide drug eluting stent
Firebird2® sirolimus eluting stent system

Measure	Description	Time Frame
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 Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D017202	Myocardial Ischemia
D003327	Coronary Disease
D054058	Acute Coronary Syndrome