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Clinical Trial of T-wave™ Coronary Lithotripsy Catheter System

Primary Purpose

Moderate to Severe Calcified Coronary Artery Stenosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
T-wave coronary lithotripsy catheter system
Sponsored by
Suzhou Zhonghui Medical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Calcified Coronary Artery Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 years old;
  2. Subjects had primary coronary artery disease suitable for percutaneous coronary intervention (including stable or unstable angina pectoris and asymptomatic myocardial ischemia)
  3. marker of myocardial injury: 3.1 For patients with unstable ischemic heart disease, the biomarker (CK-MB) must be within the normal range within 12 hours before surgery; 3.2 In patients with stable ischemic heart disease, biomarkers can be tested before or during surgery, and (CK-MB) must be within the normal range within 12 hours before or during surgery;
  4. Patients were able to understand the content of the trial, volunteered to sign the informed consent, were willing to comply with the trial protocol, and had the ability to visit and check regularly;

Image inclusion criteria:

  1. No stent has been implanted in the target lesion within 1 year, and no drug-eluting stent has been implanted within 5mm of the target lesion;
  2. Single new stenosis of the left main artery of the target vessel, or of the anterior descending branch, right crown or circumflex branch (or its branches), with the following characteristics:

    1. Visual stenosis ≥70% and <100%; or
    2. Visual stenosis ≥50% but <70%, combined with evidence of clinical ischemia, such as typical clinical symptoms or positive tablet test results, or fractional flow reserve FFR≤0.80, or instantaneous waveform free ratio instantaneous wave-free ratio<0.90;
  3. Moderate to severe calcification in the target lesion site is defined as:

    1. Angiography: Calcification can be detected in at least one location on either side of the arterial wall when the heart is beating or not under fluoroscopy before contrast medium injection; or
    2. Calcification ≥180° was present in at least one section by intravascular ultrasound.
  4. The reference diameter of target vessels was between 2.5mm and 4.0mm;
  5. Length of target lesion ≥5mm but ≤40mm;
  6. Target vessels must have thrombolysis in myocardial infarction grade 3 before registration (can be evaluated after pre-dilation)
  7. 0.014 inch guide wire can pass through the lesion;

Exclusion Criteria:

Basic condition (Cardiac function)

  1. Left ventricular ejection fraction (LVEF) <40%;
  2. New York Classification of Cardiac Function (NYHA) Class IV; Anatomical structure
  3. There is a second lesion with an interval of more than 10mm and a stenosis degree of ≥50% in the same target vessel;
  4. Target vessels were too circuitous, defined as the presence of two or more bends >90º or three or more bends >75º;
  5. Definite or probable thrombus in the target vessel;
  6. Evidence of aneurysm in the target vessel within 10mm of the target lesion;
  7. The target lesion is located in the primary vessel that can only be reached by saphenous vein or arterial graft bypass;
  8. There were restriction-limiting dissection with NHLBI (National Heart, Lung, and Blood Institute)grade ≥D in the target vessels before registration.
  9. Chronic occlusive disease (CTO) : CTO exists in other main vessels outside the target vessel (anterior descending branch, circumflex branch, right crown) or CTO exists in any location of the target vessel.
  10. Target lesions need to be pretreated with special balloons such as rotary grinding and spinous process balloon; Laboratory tests
  11. uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure > 120 mmHg);
  12. Acute myocardial infarction (MI) within the past 1 month, and/or signs of active myocardial ischemia at enrollment, including elevated troponin-I or T (with elevated CK), ischemic ECG changes, or chest pain;
  13. Severe impairment of liver and kidney function, aminotransferase more than 3 times the upper limit of normal, creatinine > 2.5 mg/dL (221 μmol/L) or chronic renal failure requiring long-term dialysis; Note: In subjects with proven or suspected acute MI (as determined by the primary and secondary investigators), markers of myocardial injury must be evaluated prior to enrollment.

    Medical history and Others

  14. 14. History of stroke or transient ischemic attack (TIA) within 30 days;
  15. Patients with active peptic ulcer or upper gastrointestinal bleeding within 30 days;
  16. Had undergone percutaneous coronary intervention within 14 days;
  17. Patients who were scheduled to undergo a cardiovascular intervention within 30 days after this procedure;
  18. Patients refuse or are not candidates for emergency coronary artery bypass grafting (CABG) surgery;
  19. Drug-eluting stents have been implanted in target vessels within the past year;
  20. Patients with known allergies or contraindications to the raw materials or drugs of the test products (such as antiplatelet drugs, anticoagulants, contrast agents);
  21. Participating in other clinical trials;
  22. The patient's expected survival was less than 1 year;
  23. Women planning to have children during pregnancy, breastfeeding or clinical trials;
  24. Factors that other researchers believe cannot be included

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Coronary lithotripsy catheter system + drug-eluting stent

    Arm Description

    Outcomes

    Primary Outcome Measures

    Success rate of operation
    After the successful passage of the experimental medical device, the residual stenosis rate of the target lesion immediately after the implantation of the drug-eluting stent was less than 50% and no MACE(Major Adverse Cardiovascular Events) occurred in the hospital after the use of the coronary shock catheter system for lumen preparation.

    Secondary Outcome Measures

    Success rate of contrast
    After successful passage of the experimental medical instruments, residual stenosis of the target lesion was < 50% after preconditioning and there were no serious angiographic complications, including flow limiting dissection (NHLBI grade D-F type)(NHLBI:National Heart, Lung, and Blood Institute) perforation, acute lumen occlusion, and persistent slow flow or no reflow.
    Operation success rate 2
    After lumen preparation using experimental medical instruments, residual stenosis rate of target lesion after drug eluting stent implantation was less than 50%, blood flow grading was TIMI level 3, and no MACE event occurred during hospitalization.
    Residual stenosis rate of target lesions after pretreatment with experimental medical instruments
    Residual stenosis rate of target lesions immediately after operation
    Thrombolysis In Myocardial Infarction blood flow grading of target lesions immediately after operation
    Major adverse cardiovascular events (MACE) event rate
    Major adverse cardiovascular and cerebrovascular events (MACCE) event rate
    Myocardial infarction rate
    Rate of revascularization
    Stent thrombosis rate
    Lumen diameter was obtained immediately after operation
    Luminal area obtained immediately after operation

    Full Information

    First Posted
    September 15, 2022
    Last Updated
    December 21, 2022
    Sponsor
    Suzhou Zhonghui Medical Technology Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05552131
    Brief Title
    Clinical Trial of T-wave™ Coronary Lithotripsy Catheter System
    Official Title
    A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Coronary Lithotripsy Catheter System for Lumen Preconditioning in Moderate-to-severe Coronary Artery Calcification
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 20, 2022 (Anticipated)
    Primary Completion Date
    May 30, 2024 (Anticipated)
    Study Completion Date
    May 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Suzhou Zhonghui Medical Technology Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    A prospective, multi-center, single-group target value method was used in this study. According to the inclusion criteria stipulated in this trial protocol, > 3 medical device clinical trial institutions with the record of the State Food and Drug Administration were selected as clinical centers, and 190 cases were selected (the first case of each center was taken as the imported case. Follow-up was carried out according to the program process, but the results were analyzed separately. Moderate-to-severe calcified stenosis patients who met all the inclusion criteria and did not meet any exclusion criteria were enrolled into the study. Lumen pretreatment was performed using the coronary shock catheter system and drug-eluting stents were implanted. Subjects were followed up immediately after surgery, before discharge, 30±3 days after surgery, and 6 months ±14 days after surgery to evaluate the safety and effectiveness of coronary lithotripsy catheter system for preconditioning patients with moderate and severe coronary artery calcification stenosis. In this study, the success rate of postoperative surgery was used as the primary endpoint, and major cardiovascular and cerebrovascular adverse events within 30 days after surgery were used as the secondary endpoint. After the completion of the primary endpoint evaluation of the project, it shall be submitted together with other data to the competent department of medical device approval for initial registration. At the same time, continue to complete the follow-up of the subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate to Severe Calcified Coronary Artery Stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    190 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Coronary lithotripsy catheter system + drug-eluting stent
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    T-wave coronary lithotripsy catheter system
    Intervention Description
    Subjects who plan to receive possible interventional therapy meet all admission criteria and do not meet any exclusion criteria, and enter the screening stage of this clinical trial after signing informed consent. All subjects who sign the informed consent will be provided with a unique subject screening number. All subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled and lumen pretreated with a coronary shock catheter system followed by the implantation of drug-eluting stents.
    Primary Outcome Measure Information:
    Title
    Success rate of operation
    Description
    After the successful passage of the experimental medical device, the residual stenosis rate of the target lesion immediately after the implantation of the drug-eluting stent was less than 50% and no MACE(Major Adverse Cardiovascular Events) occurred in the hospital after the use of the coronary shock catheter system for lumen preparation.
    Time Frame
    Immediately after the procedure
    Secondary Outcome Measure Information:
    Title
    Success rate of contrast
    Description
    After successful passage of the experimental medical instruments, residual stenosis of the target lesion was < 50% after preconditioning and there were no serious angiographic complications, including flow limiting dissection (NHLBI grade D-F type)(NHLBI:National Heart, Lung, and Blood Institute) perforation, acute lumen occlusion, and persistent slow flow or no reflow.
    Time Frame
    Immediately after using the test control advice in treatment
    Title
    Operation success rate 2
    Description
    After lumen preparation using experimental medical instruments, residual stenosis rate of target lesion after drug eluting stent implantation was less than 50%, blood flow grading was TIMI level 3, and no MACE event occurred during hospitalization.
    Time Frame
    Immediately after using the test control advice in treatment
    Title
    Residual stenosis rate of target lesions after pretreatment with experimental medical instruments
    Time Frame
    Immediately after the procedure
    Title
    Residual stenosis rate of target lesions immediately after operation
    Time Frame
    Immediately after the procedure
    Title
    Thrombolysis In Myocardial Infarction blood flow grading of target lesions immediately after operation
    Time Frame
    Immediately after the procedure
    Title
    Major adverse cardiovascular events (MACE) event rate
    Time Frame
    Immediately after the procedure、30days、180days
    Title
    Major adverse cardiovascular and cerebrovascular events (MACCE) event rate
    Time Frame
    Immediately after the procedure、30days、180days
    Title
    Myocardial infarction rate
    Time Frame
    Immediately after the procedure、30days、180days
    Title
    Rate of revascularization
    Time Frame
    Immediately after the procedure、30days、180days
    Title
    Stent thrombosis rate
    Time Frame
    Immediately after the procedure、30days
    Title
    Lumen diameter was obtained immediately after operation
    Time Frame
    Immediately after the procedure
    Title
    Luminal area obtained immediately after operation
    Time Frame
    Immediately after the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years old; Subjects had primary coronary artery disease suitable for percutaneous coronary intervention (including stable or unstable angina pectoris and asymptomatic myocardial ischemia) marker of myocardial injury: 3.1 For patients with unstable ischemic heart disease, the biomarker (CK-MB) must be within the normal range within 12 hours before surgery; 3.2 In patients with stable ischemic heart disease, biomarkers can be tested before or during surgery, and (CK-MB) must be within the normal range within 12 hours before or during surgery; Patients were able to understand the content of the trial, volunteered to sign the informed consent, were willing to comply with the trial protocol, and had the ability to visit and check regularly; Image inclusion criteria: No stent has been implanted in the target lesion within 1 year, and no drug-eluting stent has been implanted within 5mm of the target lesion; Single new stenosis of the left main artery of the target vessel, or of the anterior descending branch, right crown or circumflex branch (or its branches), with the following characteristics: Visual stenosis ≥70% and <100%; or Visual stenosis ≥50% but <70%, combined with evidence of clinical ischemia, such as typical clinical symptoms or positive tablet test results, or fractional flow reserve FFR≤0.80, or instantaneous waveform free ratio instantaneous wave-free ratio<0.90; Moderate to severe calcification in the target lesion site is defined as: Angiography: Calcification can be detected in at least one location on either side of the arterial wall when the heart is beating or not under fluoroscopy before contrast medium injection; or Calcification ≥180° was present in at least one section by intravascular ultrasound. The reference diameter of target vessels was between 2.5mm and 4.0mm; Length of target lesion ≥5mm but ≤40mm; Target vessels must have thrombolysis in myocardial infarction grade 3 before registration (can be evaluated after pre-dilation) 0.014 inch guide wire can pass through the lesion; Exclusion Criteria: Basic condition (Cardiac function) Left ventricular ejection fraction (LVEF) <40%; New York Classification of Cardiac Function (NYHA) Class IV; Anatomical structure There is a second lesion with an interval of more than 10mm and a stenosis degree of ≥50% in the same target vessel; Target vessels were too circuitous, defined as the presence of two or more bends >90º or three or more bends >75º; Definite or probable thrombus in the target vessel; Evidence of aneurysm in the target vessel within 10mm of the target lesion; The target lesion is located in the primary vessel that can only be reached by saphenous vein or arterial graft bypass; There were restriction-limiting dissection with NHLBI (National Heart, Lung, and Blood Institute)grade ≥D in the target vessels before registration. Chronic occlusive disease (CTO) : CTO exists in other main vessels outside the target vessel (anterior descending branch, circumflex branch, right crown) or CTO exists in any location of the target vessel. Target lesions need to be pretreated with special balloons such as rotary grinding and spinous process balloon; Laboratory tests uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure > 120 mmHg); Acute myocardial infarction (MI) within the past 1 month, and/or signs of active myocardial ischemia at enrollment, including elevated troponin-I or T (with elevated CK), ischemic ECG changes, or chest pain; Severe impairment of liver and kidney function, aminotransferase more than 3 times the upper limit of normal, creatinine > 2.5 mg/dL (221 μmol/L) or chronic renal failure requiring long-term dialysis; Note: In subjects with proven or suspected acute MI (as determined by the primary and secondary investigators), markers of myocardial injury must be evaluated prior to enrollment. Medical history and Others 14. History of stroke or transient ischemic attack (TIA) within 30 days; Patients with active peptic ulcer or upper gastrointestinal bleeding within 30 days; Had undergone percutaneous coronary intervention within 14 days; Patients who were scheduled to undergo a cardiovascular intervention within 30 days after this procedure; Patients refuse or are not candidates for emergency coronary artery bypass grafting (CABG) surgery; Drug-eluting stents have been implanted in target vessels within the past year; Patients with known allergies or contraindications to the raw materials or drugs of the test products (such as antiplatelet drugs, anticoagulants, contrast agents); Participating in other clinical trials; The patient's expected survival was less than 1 year; Women planning to have children during pregnancy, breastfeeding or clinical trials; Factors that other researchers believe cannot be included
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cassie Wu
    Phone
    18800263183
    Email
    cassie.wu@hh-healthcare.com

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Trial of T-wave™ Coronary Lithotripsy Catheter System

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