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Trial record 14 of 77 for:    "Heart Disease" | "Cobalt"

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

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ClinicalTrials.gov Identifier: NCT02133287
Recruitment Status : Recruiting
First Posted : May 8, 2014
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing AmsinoMed Medical Device Co., Ltd

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

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Device: AVI® Arsenic trioxide drug eluting stent delivery system Device: Firebird2® sirolimus eluting stent system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic

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



Primary Outcome Measures :
  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) [ Time Frame: at 12 months post procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133287


Contacts
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Contact: Meixiang Chai 86-10-58660666 iamsinoclinical@126.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Principal Investigator: Yong Huo, Prof.         
Sponsors and Collaborators
Beijing AmsinoMed Medical Device Co., Ltd
Investigators
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Principal Investigator: Yong Huo, Prof. Peking University First Hospital

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Responsible Party: Beijing AmsinoMed Medical Device Co., Ltd
ClinicalTrials.gov Identifier: NCT02133287     History of Changes
Other Study ID Numbers: PERFECT-II
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Diseases
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Everolimus
Arsenic Trioxide
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs