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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.