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

Lepu Medical Technology (Beijing) Co., Ltd.14 sites in 1 country170 target enrollmentMay 6, 2022

ConditionsCoronary Calcified Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Calcified Disease
Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Enrollment: 170
Locations: 14
Primary Endpoint: Procedural success rate
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 6, 2022

End Date

January 7, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Procedural success rate

Time Frame: 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 Outcomes

Device success rate(immediate post-procedure)
Target Lesion Failure (TLF)(before discharge or 7 days post-procedure, 30 days post-procedure)
Ease of use of pulsed acoustic energy generators(immediate post-procedure)
Lumen diameter obtained(immediate post sonic balloon treatment, immediate post-procedure)
Percentage of diameter stenosis(immediate post sonic balloon treatment, immediate post-procedure)
Patient-related cardiovascular clinical composite endpoint (POCE)(before discharge or 7 days post-procedure, 30 days post-procedure)
The stability of the pulse sonic energy generator(immediate post-procedure)
Confirmed and probable thrombotic events(before discharge or 7 days post-procedure, 30 days post-procedure)