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

NCT06291545 | Unknown DMC

• 1 other identifier: JW-SBC202202
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of success of the surgery

  3 days

• Incidence of in-hospital MACE

  30 days

• Incidence of PoCE within 30 days after surgery

  30 days

• The lumen is obtained immediately

  1hour

Study Arms (2)

Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）

EXPERIMENTAL

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）

ScoreFlex NC Coronary Dilatation Catheter

ACTIVE COMPARATOR

Patients with Coronary Artery Disease will be treated with ScoreFlex NC Coronary Dilatation Catheter（OrbusNeich Medical \[Netherlands\] Ltd）

Device: ScoreFlex NC Coronary Dilatation Catheter

Interventions

Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） DEVICE

One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the Coronary artery scoring balloon dilation catheter treatment group.

Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）

ScoreFlex NC Coronary Dilatation Catheter DEVICE

One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the ScoreFlex NC Coronary Dilatation Catheter treatment group.

ScoreFlex NC Coronary Dilatation 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:

• \. Voluntary participation in this trial and signed the informed consent form;
• \. Age: ≥18 and ≤80 years old, regardless of gender;
• \. 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.

You may not qualify if:

• \. Acute myocardial infarction (AMI) within 7 days before surgery;
• \. Serum creatinine level \>2.0 mg/dL (177 umol/L) within 7 days before surgery;
• \. Active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery;
• \. Stroke or transient ischemic attack (TIA) within 3 months before surgery;
• \. Known left ventricular ejection fraction (LVEF) \<30% (if LVEF is unknown, it can be measured during this surgery);
• \. Known allergies to aspirin or heparin or the existence of contraindications that prevent the subjects from receiving sufficient preoperative medications;
• \. Known subjects allergic to ingredients in the test product or contrast agent;
• \. Known subjects who are pregnant or breastfeeding;
• \. 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;
• \. Subjects participating in other drug or device clinical studies;
• \. Other situations that are not suitable for participation in this study as assessed by the investigator.

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ling Tao, Ph.D

  The First Affiliated Hospital of Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Wang, PM

CONTACT

13366024088; yang.wang@jwmsgrp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 4, 2024
• Study Start: March 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share