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

NCT02236975 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2020-07-28

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

BuMA Supreme Biodegradable drug coating coronary stent system

DEVICE

Resolute Integrity durable polymer stent system

Sponsors & Collaborators

  • Sino Medical Sciences Technology Inc.

    lead INDUSTRY

Principal Investigators

  • Clemens von.Birgelen, MD,Phd · Medisch Spectrum Twente (MST), Enschede, the Netherlands

  • Manel Sabate, MD,Phd · Clinic university hospital Barcelona, Spain

  • Patrick W.Serruys, MD,Phd · Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-11-30
Completion
2019-03-31

Countries

  • Belgium
  • Netherlands
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02236975 on ClinicalTrials.gov