Fact CheckerSign in

NCT07162792Not yet recruiting

The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT

The Safety and Efficacy of New-Generation Bioabsorbable Scaffolds Versus Drug-Coated Balloons in the Treatment of De Novo Lesions in Large Coronary Arteries: A Prospective Randomized Controlled Study

Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
1 Sept 2025
Start date
23 Oct 2025
Primary completion date
30 Dec 2027
Lead sponsor
Xuzhou Third People's Hospital
NCT number
NCT07162792

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 23 Oct 2025 to the primary completion date, 30 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 1\. in-stent lesions; 2. For the left main disease, chronic total occlusive lesions; 3. bifurcation lesion (reference vessel diameter of side branch vessels \> 2.0 mm); 4. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation; 5. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion 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;
    • Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.

Who the study is looking for

  • \- Radiography 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.