NCT05406869|Unknown

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

Lepu Medical Technology (Beijing) Co., Ltd.ClinicalTrials.gov

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1 other identifier

LP-Pulsed Sonic Balloon-2022

Study Type

interventional

Target

170

Locations

1 country

Sites

Timeline

RegisteredJun 2022

StartedMay 2022

CompletionJan 2023

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

170

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach

1 country

14 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

May 6, 2022

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed

11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2022

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2023

Completed

Last Updated

June 7, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 27, 2022

Last Update Submit

June 1, 2022

Conditions

Coronary Calcified Disease

Keywords

Coronary Sonic Balloon

Outcome Measures

Primary Outcomes (1)

Procedural success rate
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)
immediate post-procedure

Secondary Outcomes (8)

Device success rate
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
Target Lesion Failure (TLF)
before discharge or 7 days post-procedure, 30 days post-procedure
Patient-related cardiovascular clinical composite endpoint (POCE)
before discharge or 7 days post-procedure, 30 days post-procedure
+3 more secondary outcomes

Study Arms (1)

pulsed sonic balloon dilatation catheter and pulsed sonic generater

EXPERIMENTAL

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

Device: Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater

Interventions

Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic GeneraterDEVICE

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

pulsed sonic balloon dilatation catheter and pulsed sonic generater

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≤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.

You may not qualify if:

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;
Left main stem disease or bridge vascular disease;
Angiography shows that the blood vessel path is tortuous, and the test device is difficult to reach the target position or difficult to recover;
Patients with implanted pacemakers or cardiac rhythm devices;
Evidence of aneurysm within 10 mm of the target lesion;
Patients who are known to be allergic to heparin, contrast agents, aspirin, clopidogrel, and anesthetics;
+3 more criteria

Contact the study team to confirm eligibility.