Status:
COMPLETED
Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI
Lead Sponsor:
BrosMed Medical Co., Ltd
Conditions:
Atherosclerotic Plaque
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- Be between 18 and 80 years of age (including boundary values) and have a life expectancy of more than 12 months；
- 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;
- 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)；
- 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；
- 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；
- The patient had autogenous coronary angiogenesis or restenosis, requiring stent treatment；
- The reference vessel diameter of target lesion was 2.0mm-4.0mm, and the lesion length was ≤20mm；
- 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
- Patients with bleeding tendencies, contraindications to antiplatelet and anticoagulant therapy, who are unable to undergo anticoagulant therapy；
- Have had any myocardial infarction within a week；
- People who have an allergic reaction to contrast media or can't take medication
- 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；
- cardiogenic shock；
- Patients who have received heart transplants；
- Patients who are not eligible for coronary artery bypass surgery；
- The patient had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery；
- The patient had a stroke or transient ischemic attack within 2 months before surgery；
- Patients in the pregnancy or lactation period；
- Participants are currently participating in any other clinical trial within 1 month prior to the trial；
- Patients deemed unsuitable for inclusion by other investigators；
- Severe calcified lesions and twisted lesions or lesion sites \> 45 degrees angled；
- Lesions with significant endometrial tears
- Unprotected left main lesion；
- The contrast showed a blood clot；
- Scaffold fracture lesion；
- Distal stent lesion after stent implantation；
Key Trial Info
Start Date :
June 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2023
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06214754
Start Date
June 16 2023
End Date
December 28 2023
Last Update
June 6 2025
Active Locations (12)
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1
the First Affiliated Hospital of USTC
Hefei, Anhui, China
2
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
3
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China