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

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

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.

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.

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;