Clinical Trial of T-wave™ Coronary Lithotripsy Catheter System (NCT05552131) | Clinical Trial Compass
UnknownNot Applicable
Clinical Trial of T-wave™ Coronary Lithotripsy Catheter System
190 participantsStarted 2022-12-20
Plain-language summary
A prospective, multi-center, single-group target value method was used in this study. According to the inclusion criteria stipulated in this trial protocol, \> 3 medical device clinical trial institutions with the record of the State Food and Drug Administration were selected as clinical centers, and 190 cases were selected (the first case of each center was taken as the imported case. Follow-up was carried out according to the program process, but the results were analyzed separately. Moderate-to-severe calcified stenosis patients who met all the inclusion criteria and did not meet any exclusion criteria were enrolled into the study. Lumen pretreatment was performed using the coronary shock catheter system and drug-eluting stents were implanted.
Subjects were followed up immediately after surgery, before discharge, 30±3 days after surgery, and 6 months ±14 days after surgery to evaluate the safety and effectiveness of coronary lithotripsy catheter system for preconditioning patients with moderate and severe coronary artery calcification stenosis.
In this study, the success rate of postoperative surgery was used as the primary endpoint, and major cardiovascular and cerebrovascular adverse events within 30 days after surgery were used as the secondary endpoint.
After the completion of the primary endpoint evaluation of the project, it shall be submitted together with other data to the competent department of medical device approval for initial registration. At the same time, continue to complete the follow-up of the subjects.
Who can participate
Age range
18 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
. Age ≥18 years old;
. Subjects had primary coronary artery disease suitable for percutaneous coronary intervention (including stable or unstable angina pectoris and asymptomatic myocardial ischemia)
. marker of myocardial injury： 3.1 For patients with unstable ischemic heart disease, the biomarker (CK-MB) must be within the normal range within 12 hours before surgery； 3.2 In patients with stable ischemic heart disease, biomarkers can be tested before or during surgery, and (CK-MB) must be within the normal range within 12 hours before or during surgery；
. Patients were able to understand the content of the trial, volunteered to sign the informed consent, were willing to comply with the trial protocol, and had the ability to visit and check regularly;
. No stent has been implanted in the target lesion within 1 year, and no drug-eluting stent has been implanted within 5mm of the target lesion;
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.
What they're measuring
1
Success rate of operation
Timeframe: Immediately after the procedure
Trial details
NCT IDNCT05552131
SponsorSuzhou Zhonghui Medical Technology Co., Ltd.
. Single new stenosis of the left main artery of the target vessel, or of the anterior descending branch, right crown or circumflex branch (or its branches), with the following characteristics:
. Visual stenosis ≥70% and \<100%; or
. Visual stenosis ≥50% but \<70%, combined with evidence of clinical ischemia, such as typical clinical symptoms or positive tablet test results, or fractional flow reserve FFR≤0.80, or instantaneous waveform free ratio instantaneous wave-free ratio\<0.90;
Exclusion criteria
. Left ventricular ejection fraction (LVEF) \<40%;
. New York Classification of Cardiac Function (NYHA) Class IV; Anatomical structure
. There is a second lesion with an interval of more than 10mm and a stenosis degree of ≥50% in the same target vessel;
. Target vessels were too circuitous, defined as the presence of two or more bends \>90º or three or more bends \>75º;
. Definite or probable thrombus in the target vessel;
. Evidence of aneurysm in the target vessel within 10mm of the target lesion;
. The target lesion is located in the primary vessel that can only be reached by saphenous vein or arterial graft bypass;
. There were restriction-limiting dissection with NHLBI (National Heart, Lung, and Blood Institute)grade ≥D in the target vessels before registration.