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

NCT02698839 | Active Not Recruiting DMC

• 1 other identifier: PIONEER-II, RCT, P01
• Study Type: interventional
• Target: 539
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Drug eluting stents; Interventional Cardiology

Outcome Measures

Primary Outcomes (1)

• in-stent Late Lumen Loss, 9M

  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 Outcomes (7)

• Stent implantation success rate

  5 years after PCI

• Binary restenosis rate

  9 months

• in-segment LLL

  9 months

• diameter stenosis degree

  9 months

• Device-oriented Composite Endpoint (DoCE)

  1, 6, 12 month, and annually up to 5 years post procedure

Study Arms (2)

BuMA Supreme group

EXPERIMENTAL

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

BuMA™ group

ACTIVE COMPARATOR

This group contains 220 subjects.

Device: BuMA™

Interventions

BuMA Supreme DEVICE

Stent platform: cobalt-chromium alloy

BuMA Supreme group

BuMA™ DEVICE

Stent platform: stainless steel

BuMA™ group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75, male or non-pregnant female
• Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
• Target lesion is primary and de-novo coronary artery disease
• The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
• Lesion diameter stenosis ≥70% (visually estimated)
• For each target lesion, same stent implantation only
• Acceptable candidate for coronary artery bypass grafting (CABG)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge, M.D.

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Yundai Chen, M.D.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Shubin Qiao, M.D.

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• 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

  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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: March 4, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)