← Back to Search

Drug Coated Stent

BuMA Supreme Stent for Coronary Artery Disease

N/A
Waitlist Available
Led By Dean Kereiakes, MD
Research Sponsored by Sino Medical Sciences Technology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient is a male or non-pregnant female ≥20 years of age.
The patient is an acceptable candidate for percutaneous coronary intervention (PCI) with drug-eluting stents, and for emergent coronary bypass graft (CABG) surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 12 months and 5 years
Awards & highlights

Study Summary

This trial is designed to compare the safety and efficacy of a new biodegradable stent to existing durable stents in patients with up to 3 coronary lesions. Up to 1632 subjects will be enrolled at 130 sites in North America, Japan, and Europe, and followed for up to 5 years.

Who is the study for?
This trial is for adults over 20 with symptomatic ischemic heart disease needing a stent. Participants must agree to follow-up evaluations and provide informed consent. Exclusions include pregnant women, those planning pregnancy within a year, people with bleeding disorders or on chronic anticoagulation therapy, organ transplant recipients or candidates, life expectancy under one year, current participation in another study, planned surgery requiring stopping anti-platelet drugs within six months of the procedure.Check my eligibility
What is being tested?
The PIONEER III Trial is testing the BuMA Supreme biodegradable coronary stent against XIENCE or Promus durable polymer stents in patients with up to three coronary lesions. It's a global study where participants are randomly assigned to treatments in a 2:1 ratio and followed up at multiple intervals post-procedure for five years.See study design
What are the potential side effects?
Potential side effects may include reactions related to the drug-coated stents such as blood vessel re-narrowing (restenosis), blood clots (thrombosis), bleeding due to anti-platelet medication use, allergic reactions to stent materials or medications used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man or a non-pregnant woman aged 20 or older.
Select...
I am a suitable candidate for a specific heart procedure using stents and emergency heart bypass surgery.
Select...
I need a heart procedure due to my heart disease symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 12 months and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 12 months and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Target lesion failure (TLF)
Secondary outcome measures
Bleeding complications (BARC definitions)
Clinically-driven target lesion revascularization (TLR)
Clinically-driven target vessel revascularization (TVR)
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BuMA Supreme Coronary Stent SystemExperimental Treatment1 Intervention
Group II: Xience or Promus Everolimus Stent SystemActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Sino Medical Sciences Technology Inc.Lead Sponsor
9 Previous Clinical Trials
4,910 Total Patients Enrolled
8 Trials studying Coronary Artery Disease
4,638 Patients Enrolled for Coronary Artery Disease
Nova Vascular LLCUNKNOWN
Martin B Leon, MDStudy ChairCenter for Interventional Vascular Therapy - Columbia University Medical Center / New York-Presbyterian Hospital, United States
11 Previous Clinical Trials
9,506 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
1,757 Patients Enrolled for Coronary Artery Disease

Media Library

BuMA Supreme™ Drug Coated Coronary Stent (Drug Coated Stent) Clinical Trial Eligibility Overview. Trial Name: NCT03168776 — N/A
Coronary Artery Disease Research Study Groups: BuMA Supreme Coronary Stent System, Xience or Promus Everolimus Stent System
Coronary Artery Disease Clinical Trial 2023: BuMA Supreme™ Drug Coated Coronary Stent Highlights & Side Effects. Trial Name: NCT03168776 — N/A
BuMA Supreme™ Drug Coated Coronary Stent (Drug Coated Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03168776 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for enrolment in this research trial?

"Clinicaltrials.gov discloses that this trial, originally posted on October 13th 2017, is no longer recruiting patients for participation. However, 573 other clinical trials are still open to enrollment as of February 12th 2021."

Answered by AI

How many venues are hosting this experiment?

"This research is currently enrolling patients from 45 sites, including St. Michael's Hospital in Toronto, William Beaumont Hospital in Royal Oak, and Emory University Hospital in Atlanta."

Answered by AI
~220 spots leftby Mar 2025