Clinical trial NCT05406869: Clinical Trials of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Calcified Disease
Keywords: Coronary Sonic Balloon
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 18≤age≤80 years old, males or females;
2. Life expectancy ≥ 6 months;
3. Patients with evidence of asymptomatic myocardial ischemia, stability or instability; with angina, or obsolete heart infarction for interventional therapy;
4. The target lesion is primary, in situ coronary artery lesion;
5. The target vessel reference diameter is 1.5-4.0mm, and the lesion length is ≤40mm (visual inspection);
6. Target lesion is with a visually estimated stenosis of ≥70%(or≥50% with evidence of myocardial ischemia) ;
7. Highly calcified lesions;
8. Only one target lesion requiring sonic balloon treatment is allowed;
9. 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;
10. 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:

1. New York Heart Association (NYHA) class III or IV;
2. 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;
3. Stroke occurred within 6 months of joining the group, excluding transient is chemic attack (TIA) and cavity infarction;
4. Have a history of active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months of joining the group;
5. Platelet count \<80×10⁹/L;
6. Subject refuses or is not suitable for CABG surgery;
7. The target lesion is planned to undergo coronary atherectomy, laser, double guide wire balloon, mastoid balloon, cutting balloon or thrombus aspiration;
8. Dissection of the target vessel after preoperative angiography or guide wire pass through;
9. 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;
10. The target lesion is located or involved within 5mm of the opening of LAD, LCX and RCA;
11. Left main stem disease or bridge vascular disease;
12. Angiography shows that the blood vessel path is tortuous, and the test device is difficult to reach the target position or difficult to recover;
13. Patients with implanted pacemakers or cardiac rhythm devices;
14. Evidence of aneurysm within 10 mm of the target lesion;
15. Patients who are known to be allergic to heparin, contrast agents, aspirin, clopidogrel, and anesthetics;
16. The subject is currently participating in another drug or device clinical study that has not yet completed;
17. Pregnant or nursing subjects;
18. Other patients should be excluded based on the assessment of the investigators;

Primary outcomes:
measure: Procedural success rate
timeFrame: immediate post-procedure
Secondary outcomes:
measure: Device success rate
timeFrame: immediate post-procedure
measure: Lumen diameter obtained
timeFrame: immediate post sonic balloon treatment, immediate post-procedure
measure: Percentage of diameter stenosis
timeFrame: immediate post sonic balloon treatment, immediate post-procedure
measure: Target Lesion Failure (TLF)
timeFrame: before discharge or 7 days post-procedure, 30 days post-procedure
measure: Patient-related cardiovascular clinical composite endpoint (POCE)
timeFrame: before discharge or 7 days post-procedure, 30 days post-procedure
measure: Confirmed and probable thrombotic events
timeFrame: before discharge or 7 days post-procedure, 30 days post-procedure
measure: The stability of the pulse sonic energy generator
timeFrame: immediate post-procedure
measure: Ease of use of pulsed acoustic energy generators
timeFrame: immediate post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical Univesity
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-yang Hospital , Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: The Southwest Hospital of Amu
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Hunan
country: China
facility: The Second Xiangya Hospital of Central South University
city: Hunan
country: China
facility: Xiangya Hospital Central South University
city: Shanxi
country: China
facility: LinFen Central Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Xuzhou
country: China
facility: Xuzhou central hospital
city: Zhejiang
country: China
facility: Sir Run Run Shaw Hospital ZheJiang University School of Medicine
Study officials:
affiliation: Peking University Third Hospital
name: Yida Tang
role: STUDY_CHAIR
References: