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A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES) (OPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698852
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sino Medical Sciences Technology Inc.

Brief Summary:
PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: BuMA Supreme Not Applicable

Detailed Description:
Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by Sino medical science(SINOMED). BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients With de Novo Coronary Lesions, OPC Trial
Study Start Date : December 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: BuMA Supreme group
Totally 1000 subjects combined the 220 subjects from randomized controlled trial(RCT) group
Device: BuMA Supreme
Stent platform: cobalt-chromium alloy




Primary Outcome Measures :
  1. Target Lesion Failure [ Time Frame: 1 year ]
    Target Lesion Failure(TLF) is defined as cardiac death, target vessel myocardial infarction(MI), or clinically-driven target lesion revascularization (TLR).


Secondary Outcome Measures :
  1. Stent implantation success rate [ Time Frame: 5 years after PCI ]
    The stent implantation success rate includes device, lesion and clinical success rate.

  2. Device-oriented Composite Endpoint(DoCE) [ Time Frame: 1, 6, 12 month, and annually up to 5 years post procedure ]
    Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven TLR (TLF).

  3. Patient-oriented Composite Endpoint (PoCE) [ Time Frame: 1, 6, 12 month, and annually up to 5 years post procedure ]
    Patient-oriented Composite Endpoint is defined as all cause death, all MI, or any revascularization.

  4. Academic Research Consortium(ARC) defined stent thrombosis [ Time Frame: 5 years after PCI ]
    Definite and probable stent thrombosis during acute, subacute, later and very late phase.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75, male or non-pregnant female
  2. Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
  3. Target lesion is primary and de-novo coronary artery disease
  4. The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
  5. Lesion diameter stenosis ≥70% (visually estimated)
  6. For each target lesion, same stent implantation only
  7. Acceptable candidate for Coronary Artery Bypass Grafting(CABG)
  8. Understand the study purpose, willing to participate and sign the letter of consent, agrees to the follow-up visits including a 9 month angiographic follow-up

Exclusion Criteria:

  1. Acute MI within 1 week
  2. Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
  3. More than 3 stents required
  4. Patients refuse to be implanted stent
  5. Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion
  6. In-stent restenosis
  7. Planned percutaneous coronary intervention (PCI) within 3 months post procedure
  8. Other stents implanted within 1 year
  9. Severe heart failure (NYHA above III) or left ventricle ejection fraction(EF) <40%
  10. Renal function damage, blood creatinine > 176.82 μmol/L
  11. Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents
  12. Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.)
  13. Life expectation < 12 months
  14. Have not reached the primary end point when participating in other trial
  15. Poor compliance to the protocol
  16. Heart implantation cases

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): NCT02698852


Locations
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China
Zhongshan Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Sino Medical Sciences Technology Inc.
Investigators
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Principal Investigator: Junbo Ge, Ph.D. Shanghai Zhongshan Hospital
Principal Investigator: Yundai Chen, Ph.D. The General Hospital of PLA (301 hospital)
Principal Investigator: Shaoping Nie, Ph.D. Bejing Anzhen Hospital
Principal Investigator: Shubin Qiao, Ph.D. Fu Wai Hospital
Principal Investigator: Yawei Xu, Ph.D. Shanghai 10th People's Hospital
Principal Investigator: Bo Yu, Ph.D. The 2th Affiliated Hospital of Harbin Medical University
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Responsible Party: Sino Medical Sciences Technology Inc.
ClinicalTrials.gov Identifier: NCT02698852    
Other Study ID Numbers: PIONEER-II, OPC, P02
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sino Medical Sciences Technology Inc.:
Drug eluting stents
Interventional Cardiology
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases