Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Design Clinical Trial, To Evaluate the Efficacy and Safety of the Coronary Artery Notched Balloon Dilation Catheter for the Pre-dilation of Coronary Artery Stenosis Lesions

This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）; Device: ScoreFlex NC Coronary Dilatation Catheter

Detailed Description

This trial uses a prospective, multicenter, randomized controlled, non-inferiority comparison design. It is expected that the test group will be non-inferior to the control group in the main effectiveness evaluation index (device success rate). This trial plans to enroll 200 subjects who meet the requirements, and they will be randomly assigned to the test group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up for 30 days after percutaneous coronary intervention (PCI) treatment to compare the test group and the control group in the main effectiveness evaluation index (device success rate), secondary effectiveness evaluation indices (immediate lumen gain [QCA analysis], surgical success rate, in-hospital major adverse cardiac event [MACE] incidence rate, target lesion failure [TLF] incidence rate within 30 days after surgery, patient-related composite endpoints [PoCE] incidence rate during and within 30 days after surgery, device operation and performance evaluation), and safety evaluation indices (device-related complication incidence rate, adverse event/serious adverse event incidence rate, device defect incidence rate), in order to evaluate the effectiveness and safety of the coronary scoring balloon dilation catheter of the test medical device.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Wang, PM; 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. Voluntary participation in this trial and signed the informed consent form;
• 2. Age: ≥18 and ≤80 years old, regardless of gender;
• 3. The existence of coronary artery stenosis lesions accompanied by evidence of ischemia in the heart (such as symptomatic coronary heart disease, stable/unstable angina pectoris or asymptomatic myocardial ischemia), suitable for percutaneous interventional therapy.

Exclusion Criteria:

• 1. Acute myocardial infarction (AMI) within 7 days before surgery;
• 2. Serum creatinine level >2.0 mg/dL (177 umol/L) within 7 days before surgery;
• 3. Active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery;
• 4. Stroke or transient ischemic attack (TIA) within 3 months before surgery;
• 5. Known left ventricular ejection fraction (LVEF) <30% (if LVEF is unknown, it can be measured during this surgery);
• 6. Known allergies to aspirin or heparin or the existence of contraindications that prevent the subjects from receiving sufficient preoperative medications;
• 7. Known subjects allergic to ingredients in the test product or contrast agent;
• 8. Known subjects who are pregnant or breastfeeding;
• 9. Planned to use coronary atherectomy, laser ablation, other scoring / spiked / cutting balloons (non-study devices) or shock wave balloons to treat the target lesion at the same time;
• 10. Subjects participating in other drug or device clinical studies;
• 11. Other situations that are not suitable for participation in this study as assessed by the investigator.

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 scoring balloon dilation catheter（JW Medical Systems Ltd）; Patients with Coronary Artery Disease will be treated with Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）	Device: Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）; One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the Coronary artery scoring balloon dilation catheter treatment group.
Active Comparator: ScoreFlex NC Coronary Dilatation Catheter; Patients with Coronary Artery Disease will be treated with ScoreFlex NC Coronary Dilatation Catheter（OrbusNeich Medical [Netherlands] Ltd）	Device: ScoreFlex NC Coronary Dilatation Catheter; One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the ScoreFlex NC Coronary Dilatation Catheter treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful device usage	The investigational device was successfully delivered to the intended target lesion, dilated, deflated, and retrieved smoothly; After balloon angioplasty with the investigational device, the residual stenosis of the target lesion diameter was <50%.	1hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of success of the surgery	The success of the surgery is defined as on the basis of successful use of the instrument, the residual stenosis of the target lesion diameter after PCI is ≤ 30% and TIMI blood flow is grade 3, and no MACE occurs in the hospital.	3 days
Incidence of in-hospital MACE	MACE includes cardiac death, target vessel myocardial infarction, and target lesion re-vascularization	30 days
Incidence of PoCE within 30 days after surgery	PoCE includes all-cause mortality, all MIs, and any re-vascularization	30 days
The lumen is obtained immediately	The lumen is obtained immediately (QCA analysis)	1hour

Collaborators and Investigators

• Sponsor: JW Medical Systems Ltd
• Investigators: Principal Investigator: Ling Tao, Ph.D, The First Affiliated Hospital of Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: JW-SBC202202

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