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

NCT06926400 | Not Yet Recruiting

• 1 other identifier: JW-SEBC202412
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Device Procedural Success Rate

  one hour

Secondary Outcomes (9)

• Clinical treatment success rate

  one hour

• acute lumen gain,ALG

  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

Study Arms (2)

Coronary Artery Serrated Cutting Balloon Dilatation Catheter (Shandong JW Medical Products Co., Ltd.

EXPERIMENTAL

Device: Coronary artery sawtooth cutting balloon dilation catheter

Cutting Balloon Catheter

ACTIVE COMPARATOR

Device: Cutting balloon catheter

Interventions

Coronary artery sawtooth cutting balloon dilation catheter DEVICE

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.

Coronary Artery Serrated Cutting Balloon Dilatation Catheter (Shandong JW Medical Products Co., Ltd.

Cutting balloon catheter DEVICE

Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a cutting balloon catheter.

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:

• 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.

You may not qualify if:

• 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.
• 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).

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

• Yu Bo

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WangYang

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: April 1, 2025
• First Posted: April 13, 2025
• Study Start: April 10, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share