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

Not Applicable

Completed

• Conditions: Patients With Atherosclerotic Plaques in the Coronary Arteries That Require Excision
• Interventions: Procedure: PCI

• Registration Number: NCT06214754
• Lead Sponsor: BrosMed Medical Co., Ltd

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 and clinical application.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-16
• Primary Completion: 2023-08-22
• Study Completion: 2023-12-28
• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravascular high-pressure cutting balloon catheter	PCI	-
Boston Scientific Corporation	PCI	-

Primary Outcome Measures

Name	Time	Method
Device Procedural Success Rate	immediately after PTCA	In the case of balloon dilatation and stenosis, balloon delivery, balloon filling and dilatation, balloon withdrawal pressure retraction and successful balloon retraction can be successfully completed. After balloon dilatation, residual stenosis of the target lesion is less than 50%

Secondary Outcome Measures

Name	Time	Method
Clinical Success Rate	immediately after PCI	The residual lumen stenosis of the target lesion after surgery was less than 20%, the TIMI blood flow was grade 3, and there were no Major Adverse Cardiovascular Events during the follow-up period. MACE included cardiac death, myocardial infarction of the target vessel, or revascularization of the target lesion.

Trial Locations

Locations (12)

the First Affiliated Hospital of USTC; 🇨🇳 Hefei, Anhui, China

Zhongshan Hospital Affiliated to Xiamen University; 🇨🇳 Xiamen, Fujian, China

Daqing Oilfield General Hospital; 🇨🇳 Daqing, Heilongjiang, China

the second affiliated hospital of Nanchang university; 🇨🇳 Nanchang, Jiangxi, China

China-Japan Union Hospital of Jilin University; 🇨🇳 Jilin, Jilin, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China

the First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Inner Mongolia Autonomous Region People's Hospital; 🇨🇳 Hohhot, Neimenggu, China

First Affiliated Hospital of the Air Force Medical University; 🇨🇳 Xi'an, Shaanxi, China