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

September 10, 2021 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, RCT Trial

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.

Study Overview

Status

Active, not recruiting

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

Enrollment (Anticipated)

539

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

      • 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

Genders Eligible for Study

All

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Stent platform: cobalt-chromium alloy
Active Comparator: BuMA™ group
This group contains 220 subjects.
Stent platform: stainless steel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
QCA at 9-month follow-up window

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent implantation success rate
Time Frame: 5 years after PCI
The stent implantation success rate includes device success, lesion success and clinical success.
5 years after PCI
Binary restenosis rate
Time Frame: 9 months
Binary restenosis was defined in every segment (proximal, distal, and stent) as a >50% diameter.
9 months
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).
9 months
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).
9 months
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).
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 myocardial ischemia (MI), or any revascularization.
1, 6, 12 month, and annually up to 5 years post procedure
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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Junbo Ge, M.D., Shanghai Zhongshan Hospital
  • Principal Investigator: Yundai Chen, M.D., Chinese PLA General 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: Genshang Ma, M.D., Zhongda Hospital Southeast University
  • 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: Guotai Sheng, M.D., Jiangxi Provincial People's Hopital
  • Study Director: Xiandong Li, M.D., Shengjing Hospital
  • Study Director: Tingbo Jiang, M.D., The First Affiliated Hospital of Soochow University
  • Study Director: Kui Chen, M.D., The First Affiliated Hospital of Zhengzhou University
  • Study Director: Hua Wang, M.D., West China Hospital
  • Study Director: Menghong Wang, M.D., The First Affiliated Hospital of NanChang 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: Manhua Chen, M.D., Wuhan Central Hospital
  • Study Director: Yongjun Li, M.D., The Second Hospital of Hebei Medical University

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 (Actual)

December 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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