The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in… (NCT06926400) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions
182 participantsStarted 2025-04-10
Plain-language summary
To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* â‘ 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.
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