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

April 23, 2024 updated by: Sino Medical Sciences Technology Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years after PCI
Stent implantation success rate
Time Frame: 5 years after PCI
The stent implantation success rate includes device, lesion and clinical success rate.
5 years after PCI
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).
1, 6, 12 month, and annually up to 5 years post procedure
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.
1, 6, 12 month, and annually up to 5 years post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sino Medical Sciences Technology Inc.

Investigators

  • Principal Investigator: Junbo Ge, M.D., Shanghai Zhongshan Hospital
  • Principal Investigator: Shubin Qiao, M.D., Fuwai Hospital
  • Study Director: Shaoping Nie, M.D., Beijing Anzhen Hospital
  • Study Director: Yawei Xu, M.D., Shanghai 10th People's Hospital
  • Study Director: Xiangqing Kong, M.D., Jiangsu Proving Hospital
  • Study Director: Lang Li, M.D., First Affiliated Hospital of Guangxi Medical University
  • Study Director: Xiangqian Shen, M.D., Central South University
  • Study Director: Hui Li, M.D., Daqing oilfield general hospital
  • Study Director: Linghong Shen, M.D., Shanghai Chest Hospital
  • Study Director: Xi Su, M.D., Wuhan Asia Heart Hospital
  • Study Director: Jiyan Chen, M.D., Guangdong Provincial People's Hospital
  • Study Director: Xiaoshu Cheng, M.D., Second Affiliated Hospital of Nanchang University
  • Study Director: Guosheng Fu, M.D., Run Run Shaw Hospital
  • Study Director: Zesheng Xu, M.D., Cangzhou Central Hospital
  • Study Director: Jianan Wang, M.D., The Second Affiliated Hospital of Zhejiang University School of Medical College
  • Study Director: Haichu Yu, M.D., The Affiliated Hospital of Qingdao University
  • Study Director: Xiandong Li, M.D., Shengjing Hospital
  • Study Director: Tingbo Jiang, M.D., The First Affiliated Hospital of Soochow University
  • Study Director: Honghua Ye, M.D., Hua Mei Hospital, University of Chinese Academy of Sciences(Ningbo No.2 Hospital)
  • Study Director: Guohai Su, M.D., Jinan Central Hospital
  • Study Director: Yundai Chen, M.D., Chinese PLA General Hospital
  • Study Director: Bin Li, M.D., Hainan General Hospital
  • Study Director: Guotai Shen, M.D., Jiangxi Provincial People's Hopital
  • Study Director: Xianxian Zhao, M.D., Changhai Hospital
  • Study Director: Mingzhe Li, M.D., Xuzhou Central Hospital
  • Study Director: Zheng Zhang, M.D., LanZhou University
  • Study Director: Bei Shi, M.D., Zunyi Medical College
  • Study Director: Jinyu Huang, M.D., Affiliated Hangzhou First People's Hospital ,Zhengzhou University School of Medicine
  • Study Director: Hanjun Pei, M.D., The First Affiliated Hospital of BaoTou Medical College
  • Study Director: Shaobin Jia, M.D., General Hospital of Ningxia Medical University
  • Study Director: Chun Liang, M.D., Shanghai Changzheng Hospital
  • Study Director: Ronghai Man, M.D., Chifeng Municipal Hospital
  • Study Director: Jinchuan Yan, M.D., Affiliated Hospital of Jiangsu University
  • Study Director: Xuchen Zhou, M.D., The First Affiliated Hospital of Dalian Medical University
  • Study Director: Zhenyu Yang, M.D., Wuxi People's Hospital
  • Study Director: Yuehui Yin, M.D., The Second Affiliated Hospital of Chongqing Medical University
  • Study Director: Chunlai Zeng, M.D., The Central Hospital of Lishui City
  • Study Director: Kejun Huang, M.D., Henan Provincial Chest Hospital
  • Study Director: Genshang Ma, M.D., Zhongda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimated)

March 4, 2016

Study Record Updates

Last Update Posted (Estimated)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIONEER-II, OPC, P02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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