The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: … (NCT07162792) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT
150 participantsStarted 2025-10-23
Plain-language summary
This study plans to enroll 150 patients who are candidates for "intervention without implantation" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.
Who can participate
Age range
18 Years – 80 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
. angiographically confirmed de novo coronary artery lesion;
. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);
. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;
. successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria
. subjects at the age between ≥18 and ≤80 years old;
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.
. patients with symptoms or evidence of myocardial ischaemia;
. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.
Exclusion criteria
. Any patient with myocardial infarction within one month;
. Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%;
. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
. Patients with severe renal failure(eGFR\<30ml/minute) or such medical history, failure to comply with angiography conditions;
. Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;
. Patients who plans to accept selective operation within 1 year;
. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;