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

NCT ID: NCT05406869

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2023-01-07

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.

Conditions

Coronary Calcified Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pulsed sonic balloon dilatation catheter and pulsed sonic generater

All subjects will receive treatment from the pulsed sonic balloon dilatation catheter

Group Type: EXPERIMENTAL

Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater

Intervention Type: DEVICE

Deliver Pulsed Sonic Balloon Dilatation Catheter to the target vessel prior to placing a coronary stent or others

Interventions

Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater

Deliver Pulsed Sonic Balloon Dilatation Catheter to the target vessel prior to placing a coronary stent or others

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lepu Medical Technology (Beijing) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yida Tang

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

Beijing Anzhen Hospital, Capital Medical Univesity

Beijing, Beijing Municipality, China

Beijing Chao-yang Hospital , Capital Medical University

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The Southwest Hospital of Amu

Chongqing, , China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, , China

The Second Xiangya Hospital of Central South University

Hunan, , China

Xiangya Hospital Central South University

Hunan, , China

LinFen Central Hospital

Shanxi, , China

The First Affiliated Hospital of Soochow University

Suzhou, , China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

Xuzhou central hospital

Xuzhou, , China

Sir Run Run Shaw Hospital ZheJiang University School of Medicine

Zhejiang, , China

Countries

China

Other Identifiers

LP-Pulsed Sonic Balloon-2022

Identifier Type: -

Identifier Source: org_study_id