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Coronary Artery DiseaseRCTNCT02698839

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

A study testing BuMA Supreme and BuMA™ in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
BuMA Supreme and BuMA™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
539 participants
Where
1 siteChina
Study dates
Dec 2015to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Heart implantation cases

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital

    Shanghai, 200032

Other trials in China

About this study

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

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.

Read the 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.

Being tested
BuMA Supreme, BuMA™
Keywords
Drug eluting stents, Interventional Cardiology
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BuMA SupremeDevice

    Stent platform: cobalt-chromium alloy

  • BuMA™Device

    Stent platform: stainless steel

Study groups in NCT02698839
Study groupRoleWhat they receive
BuMA Supreme groupExperimentalThis group contains 319 subjects. Among them, 220 subjects will be implanted with regular specifications and 99 subjects with narrower, wider or longer ones.
Receives: Device: BuMA Supreme
BuMA™ groupActive comparatorThis group contains 220 subjects.
Receives: Device: BuMA™

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: QCA at 9-month follow-up window

Secondary outcomes (7)

  1. Stent implantation success rate

    The stent implantation success rate includes device success, lesion success and clinical success.

    Measured: 5 years after PCI

  2. Binary restenosis rate

    Binary restenosis was defined in every segment (proximal, distal, and stent) as a >50% diameter.

    Measured: 9 months

  3. in-segment LLL

    to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).

    Measured: 9 months

  4. diameter stenosis degree

    to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA).

    Measured: 9 months

  5. Device-oriented Composite Endpoint (DoCE)

    Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR).

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

  6. Patient-oriented Composite Endpoint (PoCE)

    Patient-oriented Composite Endpoint is defined as all cause death, all myocardial ischemia (MI), or any revascularization.

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

  7. Academic Research Consortium(ARC) defined stent thrombosis

    Definite and probable stent thrombosis during acute, subacute, later and very late phase.

    Measured: 5 years after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2018
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
539 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02698839
Sponsor's protocol ID
PIONEER-II, RCT, P01
Acronym
RCT
Status last verified
Apr 2024
First submitted
5 Jan 2016
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BuMA Supreme and BuMA™ in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

in-stent Late Lumen Loss, 9M (time frame: QCA at 9-month follow-up window). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02698839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

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