Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI

BrosMed Medical

Status: Completed

Conditions: Atherosclerotic Plaque

Treatments: Procedure: PCI

Study type: Interventional

Funder types: Industry

Identifiers

NCT06214754

BM-839

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to support product registration and clinical application.

Enrollment: 168 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be between 18 and 80 years of age (including boundary values) and have a life expectancy of more than 12 months；
2. Be able to understand the purpose of the study, voluntarily participate in and sign the informed consent, and be able and willing to accept the follow-up established in this study;
3. Ischemic cardiomyopathy with single or multiple coronary artery lesions and diagnostic evidence [e.g., stable angina, unstable angina, or occult ischemia (evidence of myocardial ischemia)；
4. Investigator is believed that the target atherosclerotic plaque needs to be incised and that predilation (if necessary) can enable the incised balloon to pass through the lesion；
5. The presence of coronary artery stenosis confirmed by imaging examination, suitable for percutaneous coronary intervention, coronary vessel stenosis ≥70%; Or ≥50% (visual) with evidence of ischemia, TIMI ≥ level 1；
6. The patient had autogenous coronary angiogenesis or restenosis, requiring stent treatment；
7. The reference vessel diameter of target lesion was 2.0mm-4.0mm, and the lesion length was ≤20mm；
8. When there are multiple lesions that need to be treated, only one in situ coronary lesion is selected as the target lesion, and the non-target lesion must be located on different vascular branches；

Exclusion criteria

1. Patients with bleeding tendencies, contraindications to antiplatelet and anticoagulant therapy, who are unable to undergo anticoagulant therapy；
2. Have had any myocardial infarction within a week；
3. People who have an allergic reaction to contrast media or can't take medication
4. There was severe renal failure with or without dialysis, glomerular filtration rate (eGFR) <30ml/min/1.73m2 or serum creatinine level >2.0 mg/ dl；
5. cardiogenic shock；
6. Patients who have received heart transplants；
7. Patients who are not eligible for coronary artery bypass surgery；
8. The patient had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery；
9. The patient had a stroke or transient ischemic attack within 2 months before surgery；
10. Patients in the pregnancy or lactation period；
11. Participants are currently participating in any other clinical trial within 1 month prior to the trial；
12. Patients deemed unsuitable for inclusion by other investigators；
13. Severe calcified lesions and twisted lesions or lesion sites > 45 degrees angled；
14. Lesions with significant endometrial tears
15. Unprotected left main lesion；
16. The contrast showed a blood clot；
17. Scaffold fracture lesion；
18. Distal stent lesion after stent implantation；

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Intravascular high-pressure cutting balloon catheter

Active Comparator group

Treatment:

Procedure: PCI

Boston Scientific Corporation

Active Comparator group

Treatment:

Procedure: PCI