We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05649488
Recruitment Status : Not yet recruiting
First Posted : December 14, 2022
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China. A total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon dilatation catheter and intracoronary lithotripsy apparatus after a single-group registration, clinical follow-up was carried out within 7 days after operation or before discharge, 1 month and 6 months after operation. The success rate of operation was taken as the main end point to verify the effectiveness of balloon dilatation catheter and intracoronary lithotripsy apparatus.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Intravascular Lithotripsy Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus Device: Dragonfly Opstar Imaging Catheter Not Applicable

Detailed Description:
This is a prospective, multi-center, single-group target value clinical trial to recruit patients with coronary artery calcification, coronary artery calcification was pretreated with balloon dilatation catheter and intracoronary lithotripsy apparatus made by Shanghai Blusail Boyuan Medical Technology Co. , Ltd. , to verify the safety and efficacy of balloon dilatation catheter and intracoronary lithotripsy instrument for intravascular preconditioning of coronary artery calcification lesions. This trial will be carried out in many clinical trial institutions in China, and a total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon dilatation catheter and intracoronary lithotripsy apparatus after a single-group registration, clinical follow-up was carried out within 7 days after operation or before discharge, 1 month and 6 months after operation. In this study, the success rate of operation was taken as the main end point to verify the effectiveness of balloon dilatation catheter and intracoronary lithotripsy apparatus. A clinical summary report was issued for registration of the product 1 month after completion of postoperative follow-up, based on which a 6-month postoperative follow-up was performed to assess its safety. The secondary end points were angiographic success, device success, target lesion failure at 1 and 6 months, severe angiographic complications, MACE events at 1 and 6 months, serious adverse events and adverse events, and device defects. In the OCT Subgroup, the secondary end points were the minimum stent area (MSA), the minimum stent lumen diameter (MLD), the lumen acquired diameter, the lumen acquired area, and the lumen acquired rate of the immediate postoperative, the expansion rate of the stent, and the incomplete adherence rate of the stent beam.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus for Preconditioning of Coronary Calcified Lesions in a Prospective, Multi-center, Single-group Clinical Trial
Estimated Study Start Date : December 23, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : September 22, 2025
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Experimental group
184 patients were enrolled in the experimental group
 Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus

Introduction: After the preparation, release the intracoronary lithotripsy balloon catheter to the area to be treated and release the shock wave pulse for treatment. After the balloon reaches the predetermined position, use angiography to lock the position and fill the balloon to 6 atm. After the shock wave pulse therapy, the balloon was expanded to 8 atm according to the balloon compliance table and lasted for 10s. After the treatment, unload the balloon pressure, wait for the blood flow to recover, and repeat the second treatment after an interval of one minute, two cycles, releasing a total of 20 shock wave pulses as a treatment cycle.

Therapeutic apparatus specification: IVL-HVG-C01； Specifications of balloon catheter: C20012, C20015, C22512, C22515, C25012, C25015, C27512, C27515, C30012, C30015, C32512, C32515, C35012, C35015, C37512, C37515, C40012, C40015
Optical Coherence Tomography Subgroup
70 patients in the test group were enrolled in the OCT subgroup.
 Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus

Introduction: After the preparation, release the intracoronary lithotripsy balloon catheter to the area to be treated and release the shock wave pulse for treatment. After the balloon reaches the predetermined position, use angiography to lock the position and fill the balloon to 6 atm. After the shock wave pulse therapy, the balloon was expanded to 8 atm according to the balloon compliance table and lasted for 10s. After the treatment, unload the balloon pressure, wait for the blood flow to recover, and repeat the second treatment after an interval of one minute, two cycles, releasing a total of 20 shock wave pulses as a treatment cycle.

Therapeutic apparatus specification: IVL-HVG-C01； Specifications of balloon catheter: C20012, C20015, C22512, C22515, C25012, C25015, C27512, C27515, C30012, C30015, C32512, C32515, C35012, C35015, C37512, C37515, C40012, C40015


Device: Dragonfly Opstar Imaging Catheter
OCT (optical coherence tomography) measurement using Dragonfly Opstar Imaging Catheter was performed in the OCT subgroup before or after the treatment of intracoronary lithotripsy balloon catheter and intracoronary lithotripsy therapeutic instrument, or after stent placement.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Operation success rate [ Time Frame: During hospitalization (up to 7 days after operation) ]
    After successful stent placement, the residual stenosis in the stent is ≤ 30%, and there is no residual stenosis during hospitalization (up to 7 days after surgery at most) MACE event occurs


Secondary Outcome Measures :
  1. Angiographic success rate (residual stenosis ≤ 30%) [ Time Frame: Immediately after operation ]
    Efficacy endpoint

  2. Incidence rate of MACE events 1 month and 6 months after operation [ Time Frame: 6 months after operation ]
    Security endpoint

  3. Target lesion failure (TLF) rate 1 month and 6 months after operation [ Time Frame: 6 months after operation ]
    Security endpoint

  4. Device success rate [ Time Frame: 6 months after operation ]
    Security endpoint

  5. Incidence of serious angiographic complications [ Time Frame: 6 months after operation ]
    Security endpoint

  6. Incidence rate of serious adverse events and adverse events [ Time Frame: 6 months after operation ]
    Security endpoint

  7. Incidence rate of device defects [ Time Frame: 6 months after operation ]
    Security endpoint


Other Outcome Measures:
  1. Minimum stent area (MSA) immediately after operation [ Time Frame: Immediately after operation ]
    Secondary destination of OCT subgroup

  2. Minimum stent lumen diameter (MLD) immediately after operation [ Time Frame: Immediately after operation ]
    Secondary destination of OCT subgroup

  3. Diameter of lumen obtained immediately after operation [ Time Frame: Immediately after operation ]
    Secondary destination of OCT subgroup

  4. Area of lumen obtained immediately after operation [ Time Frame: Immediately after operation ]
    Secondary destination of OCT subgroup

  5. Acquisition rate of lumen immediately after operation [ Time Frame: Immediately after operation ]
    Secondary destination of OCT subgroup

  6. Support expansion rate [ Time Frame: Immediately after operation ]
    Secondary destination of OCT subgroup

  7. Incomplete adherence rate of support beam [ Time Frame: Immediately after operation ]
    Secondary destination of OCT subgroup


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-80 years, male or non-pregnant female.
  2. Evidence of symptomatic ischemia, stable or unstable angina, or MI for more than 7 days.
  3. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to undergo angiography, OCT and clinical follow-up.

Angiogram inclusion criteria

  1. The target lesion was primary and in situ coronary artery disease.
  2. Target lesion length ≤40 mm, target lesion reference vessel diameter 2.25-4.0 mm (visual inspection).
  3. The target lesion diameter stenosis ≥70% or ≥50% (visual inspection) with evidence of ischemia.
  4. Clear, high-density shadows can be seen both when the heart is beating and when it is not.
  5. TIMI flow grade 3(allowing predilation) in the target vessel before use of the test equipment.
  6. The target lesion was the only calcified lesion to be treated with the shock wave, and the non-target lesion needed to be treated successfully before the target lesion.
  7. Suitable for patients undergoing metallic stent implantation

Exclusion Criteria:

  1. Severe myocardial infarction occurred within 7 days before operation.
  2. At the same time, the lesions were treated with rotational grinding or special balloon (chocolate balloon, nicked balloon, cutting balloon, double guide wire balloon, spinous process balloon, etc.).
  3. NYHA Class III or IV.
  4. Left ventricular ejection fraction <35% .
  5. The target lesion was expected to be treated by fully biodegradable stent implantation, drug balloon dilatation and PTCA.
  6. Uncontrollable severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg).
  7. Severe hepatic and renal impairment, transaminase more than 3 times the upper limit of normal, serum creatinine > 2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-term dialysis.
  8. Preoperative hemoglobin <100 g/l.
  9. Platelet count <60×109/L.
  10. Cerebral Stroke occurred within 6 months of enrollment, excluding transient ischemic attack (TIA) and lacunar infarction.
  11. A history of active peptic ulcer or upper gastrointestinal bleeding within 6 months before enrollment.
  12. Patients known to be allergic to heparin, contrast media, aspirin, clopidogrel and anesthetics.
  13. Definite diagnosis of malignancy or life expectancy would be less than 12 months.
  14. Participation in clinical trials of other drugs or medical devices that did not reach the primary end point.
  15. The researchers judged that the patients had poor compliance and could not complete the study according to the protocol.

Angiographic exclusion criteria:

  1. The target lesion was in the opening position (LAD, LCX or RCA, within 5 mm of the opening) or unprotected left main coronary artery.
  2. Stents were implanted 10mm proximal or distal to the target lesion.
  3. The target lesion had unprotected branch vessels more than 2.5mm in diameter.
  4. The target lesion was distal to the saphenous vein or LIMA (Left internal mammary artery) /RIMA (Right internal mammary artery) bypass graft.
  5. Existed an aneurysm within 10mm of the target lesion.
  6. Angiography confirmed the presence of severe target lesion dissection (type D-F dissection (NHLBI classification) before the treatment of the Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus
  7. The target lesion had definite thrombosis.
  8. The researchers determined that the target lesion was unsuitable for vasodilation in patients.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05649488


Contacts
Layout table for location contacts
Contact: Yanjiao Zhang, PM +8613889120902 yanjiao.zhang@jwmsgrp.com
Contact: Ying Chang, Master +8613701259639 c.chang@jwmsgrp.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Yaling Han, Ph.D The General Hospital of Northern Theater Command
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT05649488    
Other Study ID Numbers: LFBY-202201
First Posted: December 14, 2022    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases