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

NCT06214754 | Completed

• 1 other identifier: BM-839
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 12

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.

Conditions

Atherosclerotic Plaque

Outcome Measures

Primary Outcomes (1)

• Device Procedural Success Rate

  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%

  immediately after PTCA

Secondary Outcomes (1)

• Clinical Success Rate

  immediately after PCI

Study Arms (2)

Intravascular high-pressure cutting balloon catheter

ACTIVE COMPARATOR

Procedure: PCI

Boston Scientific Corporation

ACTIVE COMPARATOR

Procedure: PCI

Interventions

PCI PROCEDURE

The subjects underwent immediate coronary angiography after Percutaneous transluminal coronary angioplasty to evaluate the success rate of instruments, and immediate coronary angiography after PCI to evaluate the success rate of clinical treatment

Boston Scientific Corporation; Intravascular high-pressure cutting balloon catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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；
• 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；

Sponsors & Collaborators

• BrosMed Medical Co., Ltd: lead

Study Sites (12)

the First Affiliated Hospital of USTC

Hefei, Anhui, China

Location

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Location

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

the second affiliated hospital of Nanchang university

Nanchang, Jiangxi, China

Location

China-Japan Union Hospital of Jilin University

Jilin, Jilin, China

Location

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Neimenggu, China

Location

First Affiliated Hospital of the Air Force Medical University

Xi'an, Shaanxi, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: June 16, 2023
• Primary Completion: August 22, 2023
• Study Completion: December 28, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

CN (12)