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Coronary Calcified DiseaseNCT05406869

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

A study testing Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater in people with Coronary Calcified Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 14 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Calcified Disease
What is being tested?
Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
14 sitesChina
Study dates
6 May 2022to 7 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) ;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • The subject is currently participating in another drug or device clinical study that has not yet completed;
  • Pregnant or nursing subjects;
  • Other patients should be excluded based on the assessment of the investigators;

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Beijing Anzhen Hospital, Capital Medical Univesity

    Beijing, Beijing Municipality

  • Beijing Chao-yang Hospital , Capital Medical University

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • The Southwest Hospital of Amu

    Chongqing

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • The Second Xiangya Hospital of Central South University

    Hunan

  • Xiangya Hospital Central South University

    Hunan

  • LinFen Central Hospital

    Shanxi

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • Xuzhou central hospital

    Xuzhou

  • Sir Run Run Shaw Hospital ZheJiang University School of Medicine

    Zhejiang

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater
Keywords
Coronary Sonic Balloon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05406869
Study groupRoleWhat they receive
pulsed sonic balloon dilatation catheter and pulsed sonic generaterExperimentalAll subjects will receive treatment from the pulsed sonic balloon dilatation catheter
Receives: Device: Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: immediate post-procedure

Secondary outcomes (8)

  1. Device success rate

    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.

    Measured: immediate post-procedure

  2. Lumen diameter obtained

    Defined as the change of minimal luminal diameter[MLD] between the Follow-up points and baseline.

    Measured: immediate post sonic balloon treatment, immediate post-procedure

  3. Percentage of diameter stenosis

    Defined as (1-minimal luminal diameter[MLD]/reference vessel diameter[RVD])*100%

    Measured: immediate post sonic balloon treatment, immediate post-procedure

  4. Target Lesion Failure (TLF)

    Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

    Measured: before discharge or 7 days post-procedure, 30 days post-procedure

  5. Patient-related cardiovascular clinical composite endpoint (POCE)

    Including all-cause death, all MI, or any revascularization

    Measured: before discharge or 7 days post-procedure, 30 days post-procedure

  6. Confirmed and probable thrombotic events

    Including Acute thrombosis, Early thrombosis, Late thrombosis, Very late thrombosis.

    Measured: before discharge or 7 days post-procedure, 30 days post-procedure

  7. The stability of the pulse sonic energy generator

    Including excellent, good and poor levels

    Measured: immediate post-procedure

  8. Ease of use of pulsed acoustic energy generators

    Including excellent, good and poor levels

    Measured: immediate post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start6 May 2022
  3. Primary completion7 Oct 2022 (estimated)
  4. Study completion7 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05406869
Sponsor's protocol ID
LP-Pulsed Sonic Balloon-2022
Status last verified
May 2022
First submitted
27 May 2022
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater in people with Coronary Calcified Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success rate (time frame: immediate post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05406869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.

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