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

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ClinicalTrials.gov Identifier: NCT02698839
Recruitment Status : 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 RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. 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 Device: BuMA™ 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 SINOMED. BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 539 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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, RCT Trial
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: BuMA Supreme group
This group contains 319 subjects. Among them, 220 subjects will be implanted with regular specifications and 99 subjects with narrower, wider or longer ones.
Device: BuMA Supreme
Stent platform: cobalt-chromium alloy

Active Comparator: BuMA™ group
This group contains 220 subjects.
Device: BuMA™
Stent platform: stainless steel




Primary Outcome Measures :
  1. in-stent Late Lumen Loss, 9M [ Time Frame: QCA at 9-month follow-up window ]
    The primary endpoint is in-stent Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).


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

  2. Binary restenosis rate [ Time Frame: 9 months ]
    Binary restenosis was defined in every segment (proximal, distal, and stent) as a >50% diameter.

  3. in-segment LLL [ Time Frame: 9 months ]
    to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).

  4. diameter stenosis degree [ Time Frame: 9 months ]
    to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA).

  5. 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 target lesion revascularization (TLR).

  6. 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 myocardial ischemia (MI), or any revascularization.

  7. 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.



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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): NCT02698839


Contacts
Contact: Junbo Ge, Ph.D. +86-021-64041990 ext 2745 ge.junbo@zs-hospital.sh.cn
Contact: Lei Ge, Ph.D. 13816112695 ge.lei@zs-hospital.sh.cn

Locations
China
Zhongshan Hospital Recruiting
Shanghai, China, 200032
Contact: Junbo Ge, Ph.D    +86-021-64041990 ext 2745    ge.junbo@zs-hospital.sh.cn   
Sponsors and Collaborators
Sino Medical Sciences Technology Inc.
Investigators
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

Responsible Party: Sino Medical Sciences Technology Inc.
ClinicalTrials.gov Identifier: NCT02698839     History of Changes
Other Study ID Numbers: PIONEER-II, RCT, P01
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants