NCT02236975

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 28, 2020

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

September 4, 2014

Last Update Submit

July 24, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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.

    Up to 9 month

Secondary Outcomes (9)

  • Angiographic endpoint

    9 and 12 month

  • Angiographic endpoint

    9 and 12 month

  • Angiographic endpoint

    9 and 12 month

  • Angiographic endpoint

    9 and 12 month

  • Clinical endpoint

    9 and 12 month

  • +4 more secondary outcomes

Study Arms (2)

BuMA Supreme Biodegradable drug coating coronary stent system

EXPERIMENTAL

Implant BuMA Supreme stent only

Device: BuMA Supreme Biodegradable drug coating coronary stent system

Resolute Integrity durable polymer stent system

ACTIVE COMPARATOR

Implant Resolute stent

Device: Resolute Integrity durable polymer stent system

Interventions

BuMA Supreme Biodegradable drug coating coronary stent systemDEVICE
BuMA Supreme Biodegradable drug coating coronary stent system
Resolute Integrity durable polymer stent systemDEVICE
Resolute Integrity durable polymer stent system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Imelda Hospital

Bonheiden, Belgium

Location

CHU Chaleroi

Chaleroi, Belgium

Location

Oost-limburg Hospital

Genk, Belgium

Location

AMC

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

UMCG

Groningen, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

Hospita; Garcia de Orta

Almada, Portugal

Location

Santa Maria University Hospital

Lisbon, Portugal

Location

Gaia/Espinho Hospital Centers

Porto, Portugal

Location

University Hospital Madrid

Madrid, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Spain

Location

Related Publications (1)

  • 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.

    PMID: 34666500DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Clemens von.Birgelen, MD,Phd

    Medisch Spectrum Twente (MST), Enschede, the Netherlands

    PRINCIPAL INVESTIGATOR

  • Manel Sabate, MD,Phd

    Clinic university hospital Barcelona, Spain

    PRINCIPAL INVESTIGATOR

  • Patrick W.Serruys, MD,Phd

    Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 11, 2014

Study Start

April 1, 2015

Primary Completion

November 1, 2016

Study Completion

March 1, 2019

Last Updated

July 28, 2020

Record last verified: 2016-08

Locations

ES(2)NL(4)BE(3)PT(3)