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

Not Applicable

• Conditions: Coronary Calcified Disease
• Interventions: Device: Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater

• Registration Number: NCT05406869
• Lead Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.

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.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-06
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-01
• Last Update Submitted: 2022-06-01
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07
• Primary Completion: 2022-10-07
• Study Completion: 2023-01-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pulsed sonic balloon dilatation catheter and pulsed sonic generater	Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater	All subjects will receive treatment from the pulsed sonic balloon dilatation catheter

Primary Outcome Measures

Name	Time	Method
Procedural success rate	immediate post-procedure	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)

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Xiangya Hospital Central South University; 🇨🇳 Hunan, China

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Hunan, China

Beijing Anzhen Hospital, Capital Medical Univesity; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Sir Run Run Shaw Hospital ZheJiang University School of Medicine; 🇨🇳 Zhejiang, China

Beijing Chao-yang Hospital , Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

The Southwest Hospital of Amu; 🇨🇳 Chongqing, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

LinFen Central Hospital; 🇨🇳 Shanxi, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China

Xuzhou central hospital; 🇨🇳 Xuzhou, China