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AzTrials

Coronary Artery DiseasePhase 2/3NCT02236975

First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis

A Phase 2/3 study testing BuMA Supreme Biodegradable drug coating coronary stent system and Resolute Integrity durable polymer stent system in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc. at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal. Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
BuMA Supreme Biodegradable drug coating coronary stent system and Resolute Integrity durable polymer stent system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
12 sitesin 4 countries
Study dates
Apr 2015to Mar 2019
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is at least 18 years of age.
  • Clinical evidence of ischemic heart disease and/or a positive territorial functional study.
  • Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
  • The patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA).
  • Diameter Stenosis≥50 and<100%.
  • The visually estimated target lesion must be able to be covered by a single BuMA Supreme stent or a single Resolute Integrity stent (for available sizes refer to tables 1 and 2, page 20 and 21).
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  • The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter.
  • Written informed consent.
  • The patient agrees to the follow-up visits including a 9 month angiographic follow-up.
  • Patient must have completed the follow-up phase of any previous study.

Who cannot join

  • Female of child bearing potential (age <50 years and last menstruation within the last 12 months). Subjects with age <50 who underwent tubal ligation, ovariectomy or hysterectomy can be included.
  • Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
  • Patient suffered from stroke/TIA during the last 6 months.
  • LVEF <30%
  • Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment).
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  • Patient undergoing planned surgery within 6 months with the necessity to stop DAPT.
  • Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC))
  • History of bleeding diathesis or coagulopathy
  • The patient is a recipient of a heart transplant
  • Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium.
  • Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
  • The patient is simultaneously participating in another investigational device or drug study

Trial locations and contacts

12 sites in 4 countries.

12 sites in 4 countries

Netherlands4 sites

  • AMC

    Amsterdam

  • OLVG

    Amsterdam

  • UMCG

    Groningen

  • Maasstad Hospital

    Rotterdam

Other trials in Netherlands

Belgium3 sites

  • Imelda Hospital

    Bonheiden

  • CHU Chaleroi

    Chaleroi

  • Oost-limburg Hospital

    Genk

Other trials in Belgium

Portugal3 sites

  • Hospita; Garcia de Orta

    Almada

  • Santa Maria University Hospital

    Lisbon

  • Gaia/Espinho Hospital Centers

    Porto

Other trials in Portugal

Spain2 sites

  • University Hospital Madrid

    Madrid

  • Hospital Álvaro Cunqueiro

    Vigo

Other trials in Spain

About this study

Official title: Prospective, Multi-center, Randomized First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme eG (Electro Grafting) Based Biodegradable Polymer Sirolimus-eluting Stent and Resolute Integrity Zotarolimus-eluting Durable Polymer Stent in Patients With de Novo Coronary Artery Stenosis.

Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal.

Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.

Being tested
BuMA Supreme Biodegradable drug coating coronary stent system, Resolute Integrity durable polymer stent system
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 Supreme Biodegradable drug coating coronary stent systemDevice

  • Resolute Integrity durable polymer stent systemDevice

Study groups in NCT02236975
Study groupRoleWhat they receive
BuMA Supreme Biodegradable drug coating coronary stent systemExperimentalImplant BuMA Supreme stent only
Receives: Device: BuMA Supreme Biodegradable drug coating coronary stent system
Resolute Integrity durable polymer stent systemActive comparatorImplant Resolute stent
Receives: Device: Resolute Integrity durable polymer stent system

What is being measured

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

  1. Late Lumen Loss

    The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA.

    Measured: Up to 9 month

Secondary outcomes (9)

  1. Angiographic endpoint

    Acute Lumen Gain (mm);

    Measured: 9 and 12 month

  2. Angiographic endpoint

    MLD (mm) post procedure and at 9 months;

    Measured: 9 and 12 month

  3. Angiographic endpoint

    Diameter Stenosis (%) post procedure and at 9 months;

    Measured: 9 and 12 month

  4. Angiographic endpoint

    Binary Restenosis (DS ≥50%) at 9 months

    Measured: 9 and 12 month

  5. Clinical endpoint

    Acute success (device and procedural success)

    Measured: 9 and 12 month

  6. Cinical endpoint

    Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 months and its individual components. (Device-oriented Composite Endpoint is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated Target Lesion Revascularization).

    Measured: 9 and 12 month

  7. Clinical endpoint

    Myocardial infarction (Q-wave, Non q-wave) at all time points.

    Measured: 9 and 12 month

  8. Clinical endpoint

    Any revascularization at all time points.

    Measured: 9 and 12 month

  9. Clinical endpoint

    Stent thrombosis according to the ARC definitions up to 12 months follow-up.

    Measured: 9 and 12 month

Timeline

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

  1. First posted11 Sep 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionNov 2016
  4. Study completionMar 2019

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02236975
Sponsor's protocol ID
PIONEER
Status last verified
Aug 2016
First submitted
4 Sep 2014
Last updated
28 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.

    PubMed 34666500

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BuMA Supreme Biodegradable drug coating coronary stent system and Resolute Integrity durable polymer stent system in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc. at 12 sites in 4 countries.

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 10 inclusion and 13 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: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Netherlands, Belgium, Portugal, Spain. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Late Lumen Loss (time frame: Up to 9 month). 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 NCT02236975, which also lists 1 linked publication.

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 28 Jul 2020.

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