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 range18 Years – 80 Years
SexALL
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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;
✓. 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;