- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406869
Clinical Trials of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater
June 1, 2022 updated by: Lepu Medical Technology (Beijing) Co., Ltd.
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chongqing, China
- The Southwest hospital of AMU
-
Guangzhou, China
- The First Affiliated Hospital, Sun Yat-sen University
-
Hunan, China
- Xiangya Hospital Central South University
-
Hunan, China
- The Second Xiangya Hospital of Central South University
-
Shanxi, China
- Linfen Central Hospital
-
Suzhou, China
- The First Affiliated Hospital of Soochow University
-
Wuhan, China
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
Xuzhou, China
- Xuzhou Central Hospital
-
Zhejiang, China
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
-
-
Beijing
-
Beijing, Beijing, China
- Peking University Third Hospital
-
Beijing, Beijing, China
- Peking University First Hospital
-
Beijing, Beijing, China
- Peking University People's Hospital
-
Beijing, Beijing, China
- Beijing Anzhen Hospital, Capital Medical Univesity
-
Beijing, Beijing, China
- Beijing Chao-Yang Hospital , Capital Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
- 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: pulsed sonic balloon dilatation catheter and pulsed sonic generater
All subjects will receive treatment from the pulsed sonic balloon dilatation catheter
|
Deliver Pulsed Sonic Balloon Dilatation Catheter to the target vessel prior to placing a coronary stent or others
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
immediate post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device success rate
Time Frame: immediate post-procedure
|
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.
|
immediate post-procedure
|
Lumen diameter obtained
Time Frame: immediate post sonic balloon treatment, immediate post-procedure
|
Defined as the change of minimal luminal diameter[MLD] between the Follow-up points and baseline.
|
immediate post sonic balloon treatment, immediate post-procedure
|
Percentage of diameter stenosis
Time Frame: immediate post sonic balloon treatment, immediate post-procedure
|
Defined as (1-minimal luminal diameter[MLD]/reference vessel diameter[RVD])*100%
|
immediate post sonic balloon treatment, immediate post-procedure
|
Target Lesion Failure (TLF)
Time Frame: before discharge or 7 days post-procedure, 30 days post-procedure
|
Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.
|
before discharge or 7 days post-procedure, 30 days post-procedure
|
Patient-related cardiovascular clinical composite endpoint (POCE)
Time Frame: before discharge or 7 days post-procedure, 30 days post-procedure
|
Including all-cause death, all MI, or any revascularization
|
before discharge or 7 days post-procedure, 30 days post-procedure
|
Confirmed and probable thrombotic events
Time Frame: before discharge or 7 days post-procedure, 30 days post-procedure
|
Including Acute thrombosis, Early thrombosis, Late thrombosis, Very late thrombosis.
|
before discharge or 7 days post-procedure, 30 days post-procedure
|
The stability of the pulse sonic energy generator
Time Frame: immediate post-procedure
|
Including excellent, good and poor levels
|
immediate post-procedure
|
Ease of use of pulsed acoustic energy generators
Time Frame: immediate post-procedure
|
Including excellent, good and poor levels
|
immediate post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 6, 2022
Primary Completion (ANTICIPATED)
October 7, 2022
Study Completion (ANTICIPATED)
January 7, 2023
Study Registration Dates
First Submitted
May 27, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (ACTUAL)
June 7, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 7, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP-Pulsed Sonic Balloon-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Calcified Disease
-
Rede Optimus Hospitalar SARecruiting
-
Baim Institute for Clinical ResearchC. Michael Gibson, MS, MD; Akiko Maehara, MD; Robert W. Yeh, MD; Ajay Kirtane, MD; Kathleen Kearney,... and other collaboratorsNot yet recruitingTreatment in Calcified Coronary DiseaseUnited States
-
Segeberger Kliniken GmbHCompleted
-
Deutsches Herzzentrum MuenchenAbbott Medical Devices; SIS Medical AGRecruitingCalcified Coronary Artery DiseaseGermany
-
Samsung Medical CenterNot yet recruitingCoronary Atherosclerosis Due to Calcified Coronary Lesion
-
Deutsches Herzzentrum MuenchenSIS Medical AGCompletedCalcified Coronary Artery Disease (Grade 3)Germany, Switzerland
-
Clinica MediterraneaCompletedChronic Total Occlusion of Coronary Artery | Coronary Atherosclerosis Due to Calcified Coronary LesionItaly
-
Segeberger Kliniken GmbHCompletedCoronary Atherosclerosis Due to Severely Calcified Coronary LesionGermany
-
Xijing HospitalRecruitingDe Novo Stenosis | Severely Calcified Coronary StenosesChina
-
Suzhou Zhonghui Medical Technology Co., Ltd.Not yet recruitingModerate to Severe Calcified Coronary Artery Stenosis
Clinical Trials on Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater
-
Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingAutism Spectrum Disorder | Autistic Disorder | Fragile X Syndrome | Asperger SyndromeUnited States
-
Ningbo No. 1 HospitalCompletedParoxysmal Supraventricular TachycardiaChina
-
Shanghai MicroPort EP MedTech Co., Ltd.Active, not recruitingParoxysmal Supraventricular TachycardiaChina
-
Centre Hospitalier Universitaire de NiceCompletedDysfunction of Hemodialysis Vascular Access (Fistula and Graft)France
-
ZhuHai Cardionovum Medical Device Co., Ltd.CompletedPeripheral Arterial Disease | FistulaChina
-
Zhejiang Zylox Medical Device Co., Ltd.Active, not recruitingIntracranial AtherosclerosisChina
-
ZhuHai Cardionovum Medical Device Co., Ltd.Unknown
-
BrosMed Medical Co., LtdChinese Academy of Medical Sciences, Fuwai HospitalNot yet recruiting
-
Shanghai MicroPort EP MedTech Co., Ltd.RecruitingPersistent Atrial FibrillationChina
-
Charles University, Czech RepublicUniversity Hospital Ostrava; Brno University Hospital; Regional Hospital Liberec and other collaboratorsNot yet recruitingAtrial Fibrillation | Pulsed-field Ablation | Functional Exercise TestingCzechia