Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Cor… (NCT06291545) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions
200 participantsStarted 2024-03-20
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 su…