Status:
NOT_YET_RECRUITING
The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions
Lead Sponsor:
JW Medical Systems Ltd
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
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 s...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06926400
Start Date
April 10 2025
End Date
March 30 2026
Last Update
April 13 2025
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