Status:
NOT_YET_RECRUITING
The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT
Lead Sponsor:
Xuzhou Third People's Hospital
Conditions:
Coronary Artery Disease(CAD)
de Novo Coronary Lesions
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 scaff...
Eligibility Criteria
Inclusion
- \- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07162792
Start Date
October 23 2025
End Date
December 30 2028
Last Update
September 9 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.