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

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, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
539

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sino Medical Sciences Technology Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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: 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: 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIONEER-II, RCT, P01

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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