Clinical Trials of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater

Study Overview
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Brief Summary
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The prospective, multicenter, single- arm study is designed to verify the safety and efficacy of pulsed sonic balloon dilatation catheter and pulsed sonic generater in the treatment of coronary calcification lesions.

Detailed Description
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The study will include a total of 170 patients with calcified coronary lesions who will be treated with pulsed sonic balloon dilatation catheter and pulsed sonic generater. Optical coherence tomography (OCT) imaging subgroups of 30 patients were designed in 1-2 centers to further accurately assess the treatment effect of calcified lesions.

Official Title
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A Prospective, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater in the Treatment of Coronary Calcified Lesions

Conditions
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Coronary Calcified Disease

Intervention / Treatment
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* Device: Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18≤age≤80 years old, males or females; Life expectancy ≥ 6 months; Patients with evidence of asymptomatic myocardial ischemia, stability or instability; with angina, or obsolete heart infarction for interventional therapy; The target lesion is primary, in situ coronary artery lesion; The target vessel reference diameter is 1.5-4.0mm, and the lesion length is ≤40mm (visual inspection); Target lesion is with a visually estimated stenosis of ≥70%(or≥50% with evidence of myocardial ischemia) ; Highly calcified lesions; Only one target lesion requiring sonic balloon treatment is allowed; The number of non-target lesions requiring interventional treatment is no more than 2, and the target lesions should be treated after the non-target lesions are successfully treated; Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and can accept required clinical follow-up. Exclusion Criteria: New York Heart Association (NYHA) class III or IV; Severe liver and kidney damage, transaminase more than 3 times the upper limit of normal, creatinine > 2.5mg/dL (221μmol/L) or chronic renal failure requiring long-term dialysis; Stroke occurred within 6 months of joining the group, excluding transient is chemic attack (TIA) and cavity infarction; Have a history of active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months of joining the group; Platelet count <80×10⁹/L; Subject refuses or is not suitable for CABG surgery; The target lesion is planned to undergo coronary atherectomy, laser, double guide wire balloon, mastoid balloon, cutting balloon or thrombus aspiration; Dissection of the target vessel after preoperative angiography or guide wire pass through; The stent has been implanted within 10mm of the proximal or distal end of the target lesion, and there is a definite or possible thrombus in the target vessel; The target lesion is located or involved within 5mm of the opening of LAD, LCX and RCA; Left main stem disease or bridge vascular disease; Angiography shows that the blood vessel path is tortuous, and the test device is difficult to reach the target position or difficult to recover; Patients with implanted pacemakers or cardiac rhythm devices; Evidence of aneurysm within 10 mm of the target lesion; Patients who are known to be allergic to heparin, contrast agents, aspirin, clopidogrel, and anesthetics; The subject is currently participating in another drug or device clinical study that has not yet completed; Pregnant or nursing subjects; Other patients should be excluded based on the assessment of the investigators;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pulsed sonic balloon dilatation catheter and pulsed sonic generater<br>All subjects will receive treatment from the pulsed sonic balloon dilatation catheter | Device: Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater<br>* Deliver Pulsed Sonic Balloon Dilatation Catheter to the target vessel prior to placing a coronary stent or others<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate | Procedural success was defined as residual stenosis ≤30% after successful stent delivery without the occurrence of in-hospital adverse cardiac events (include cardiac death, target vessel-related myocardial infarction (TV-MI) and target lesion revascularizition) | immediate post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success rate | Device success was defined as residual stenosis ≤50% with the successful delivery, deployment and withdrawal of pulsed acoustic wave balloon dilatation catheter to the target lesion. | immediate post-procedure | 
| Lumen diameter obtained | Defined as the change of minimal luminal diameter[MLD] between the Follow-up points and baseline. | immediate post sonic balloon treatment, immediate post-procedure | 
| Percentage of diameter stenosis | Defined as (1-minimal luminal diameter[MLD]/reference vessel diameter[RVD])*100% | immediate post sonic balloon treatment, immediate post-procedure | 
| Target Lesion Failure (TLF) | Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization. | before discharge or 7 days post-procedure, 30 days post-procedure | 
| Patient-related cardiovascular clinical composite endpoint (POCE) | Including all-cause death, all MI, or any revascularization | before discharge or 7 days post-procedure, 30 days post-procedure | 
| Confirmed and probable thrombotic events | Including Acute thrombosis, Early thrombosis, Late thrombosis, Very late thrombosis. | before discharge or 7 days post-procedure, 30 days post-procedure | 
| The stability of the pulse sonic energy generator | Including excellent, good and poor levels | immediate post-procedure | 
| Ease of use of pulsed acoustic energy generators | Including excellent, good and poor levels | immediate post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Sonic Balloon