A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES) (NCT02698852) | Clinical Trial Compass
UnknownNot Applicable
A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
China1,000 participantsStarted 2015-12
Plain-language summary
PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
. For each target lesion, same stent implantation only
. Acceptable candidate for Coronary Artery Bypass Grafting(CABG)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. 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
. Planned percutaneous coronary intervention (PCI) within 3 months post procedure