The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter for the Predilation of Coronary Artery Stenosis Lesions

To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Coronary artery sawtooth cutting balloon dilation catheter; Device: Cutting balloon catheter

Detailed Description

This study is a prospective, multicenter, randomized controlled, non-inferiority designed clinical trial. It is planned to enroll a total of 182 eligible subjects from multiple research centers. The subjects will be randomly assigned to the experimental group (n = 91) and the control group (n = 91) in a 1:1 ratio. All subjects will undergo immediate coronary angiography after percutaneous transluminal coronary angioplasty (PTCA) to evaluate the success rate of the device.

• Study Type: Interventional
• Enrollment (Estimated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WangYang; Phone Number: 13366024088; Email: yang.wang@jwmsgrp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ① The age is between 18 and 80 years old (including the boundary values), and the subjects are male or non-pregnant female.

  • Have single or multiple coronary artery lesions and diagnosed ischemic heart disease (for example: stable angina pectoris, unstable angina pectoris, old myocardial infarction or asymptomatic myocardial ischemia).

    • There are coronary artery stenosis lesions confirmed by coronary angiography, which are suitable for percutaneous coronary intervention. The coronary artery stenosis is ≥ 70% (by visual estimation); or ≥ 50% (by visual estimation) and accompanied by evidence of ischemia, and the TIMI blood flow is ≥ Grade 1.

      • There are de novo or restenosis lesions in the coronary arteries of autologous or bypass graft vessels, and interventional treatment is required.

        • The visually estimated reference vessel diameter of the target lesion is 2.0mm - 4.0mm, and the lesion length is ≤ 20mm.

          • When there are multiple lesions that need to be treated, only one coronary artery lesion is selected as the target lesion, and the non-target lesions must be located on different vascular branches.

Be able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and be able to and willing to accept the follow-up as specified in this trial.

Exclusion Criteria:

• General Exclusion Criteria

  • Patients with New York Heart Association (NYHA) Class IV heart failure.

    • Patients with contraindications to anti - platelet and anticoagulant therapy and are unable to receive anticoagulant treatment.

      • Patients who have had any myocardial infarction within one week.

        • Patients with an allergic reaction to contrast agents. ⑤ Patients with severe renal failure, with a serum creatinine level > 2.0 mg/dl (177 μmol/L).

          • Patients who have undergone heart transplantation.

            • Patients who have had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery.

              ⑧ Patients who have had a stroke or transient ischemic attack within 3 months before surgery.

              • Pregnant or lactating patients. ⑩ Patients who are currently participating in any other clinical trials. ⑪ Patients whom the investigator deems unsuitable for enrollment. Exclusion Criteria Related to the Target Lesion (Detected by Coronary Angiography)

  • Tortuous lesions or lesions with an angulation of ≥ 45 degrees at the lesion site.

    • Lesions at the ostium with a distance of ≤ 2 mm from the left main coronary artery.

      • Unprotected left main coronary artery lesions. ④ Coronary angiography shows the presence of thrombus. ⑤ Before using the test device or the control device, the target lesion has a dissection of Type C or higher.

Target lesions that require treatment with coronary atherectomy or special balloons (such as scored balloons, spiked balloons, shock - wave lithotripsy systems, and cutting balloons of other brands).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coronary Artery Serrated Cutting Balloon Dilatation Catheter (Shandong JW Medical Products Co., Ltd.	Device: Coronary artery sawtooth cutting balloon dilation catheter; Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a coronary artery sawtooth cutting balloon dilation catheter.
Active Comparator: Cutting Balloon Catheter	Device: Cutting balloon catheter; Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a cutting balloon catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device Procedural Success Rate	one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical treatment success rate		one hour
acute lumen gain,ALG	Immediate lumen gain is defined as: ALG = the immediate minimum lumen diameter after balloon dilation - the minimum lumen diameter before the operation.	one hour
The incidence of the composite endpoint of target lesion failure (TLF) within 30 days after surgery		30 days
The incidence of patient-related cardiovascular clinical composite endpoint (POCE) within 30 days after surgery		30 days
The incidence of major adverse cardiac events (MACE) within 30 days after surgery		30 days
Evaluation of Device Performance	CRF	one hour
The incidence rate of medical device-related complications		one hour
The incidence rate of device defects		one hour
The incidence rate of adverse events and serious adverse events		thirty days

Collaborators and Investigators

• Sponsor: JW Medical Systems Ltd
• Investigators: Principal Investigator: Yu Bo, The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: JW-SEBC202412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No