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Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter

Primary Purpose

Calcified Atheroma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electrohydraulic shock wave lithotripsy
Rotary atherectomy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcified Atheroma focused on measuring Calcified coronary lesions, Rotary atherectomy, Electrohydraulic shock wave lithotripsy, Optical coherence tomography (OCT)

Eligibility Criteria

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

Inclusion Criteria: Clinical Criteria: Age ≥ 18 years old Evidence of asymptomatic ischemia, stable or unstable angina Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to accept angiography, OCT examination and clinical follow-up. Angiographic Criteria: The target lesion is primary and in situ coronary artery lesion The length of the target lesion is ≤60mm, and the diameter of the target lesion is 2.5-4.0mm (visually) The stenosis rate of the target lesion diameter is ≥70%, and the doctor judges that it is necessary to implant a stent (visual inspection method) to meet one of the following: Diameter stenosis ≥ 70%, < 100% ≥50%, <70% with evidence of ischemia The lesion allows a 0.014 guidewire to pass Under multi-angle imaging conditions, calcified shadow lesions can be seen on both sides of the lesion vessel wall (the target lesion meets the definition of severe calcification) Exclusion Criteria: Clinical Criteria: Acute myocardial infarction occurred within 30 days before operation Use special balloons (chocolate balloons, scored balloons, spinous balloons, etc.) to treat lesions at the same time Troponin is greater than 5 times the upper limit of laboratory normal value within one week before operation Severe cardiac dysfunction (grade III or IV) Left ventricular ejection fraction <25% The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery Severe uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg) Severe renal failure (serum creatinine > 221 μmol/L) Preoperative hemoglobin <100g/L Obvious coagulation dysfunction (platelet count<100×109/L or INR>1.7, INR is only required for patients who have taken warfarin orally within 2 weeks before enrollment) Blood hypercoagulability diseases (such as polycythemia vera, platelet count >750×109/L, etc.) History of stroke or TIA within 3 months History of active peptic ulcer or upper gastrointestinal bleeding within 6 months The life expectancy of the patient is less than 12 months The patient has an active systemic infection The patient has a connective tissue disorder (such as Marfan syndrome) Patient is allergic to contrast material Patients undergoing heart transplantation Patients with implanted cardiac pacemakers The patient is pregnant or breastfeeding Those who have participated in clinical trials of other drugs or medical devices within one month before enrollment; Other circumstances that the investigator considers inappropriate to participate in the trial Angiographic Criteria: Unprotected left main lesion (left main visual stenosis >50%) Baseline TIMI blood flow is less than grade 3 (evaluation after pre-dilation is allowed) A stent has been implanted within 10mm of the proximal or distal end of the target lesion The target lesion is located distal to the saphenous vein or LIMA/RIMA bypass graft Aneurysm in the target vessel Angiography confirmed the presence of thrombus in the target vessel Chronic total occlusive disease Angiography confirmed the presence of severe dissection of the target lesion before hydroelectric shock wave lithotripsy (D-F type dissection (NHLBI classification) The investigator judged that the target lesion is not suitable for patients with vasodilation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Electrohydraulic shock wave lithotripsy

    Rotary atherectomy

    Arm Description

    Pre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy

    Pre-treatment of severe calcified coronary lesions with Rotary atherectomy

    Outcomes

    Primary Outcome Measures

    Stent expansion rate using OCT
    Stent expansion rate=Minimum lumen area in the stent/(distal reference vessel area + proximal reference vessel area)*1/2

    Secondary Outcome Measures

    Angiography success rate
    Minimum stent area (MSA) immediately after surgery
    Minimum lumen diameter MLD immediately after operation
    The diameter of the lumen immediately after operation
    Obtained lumen area immediately after operation
    Lumen acquisition rate immediately after operation
    Incomplete apposition rate of stent
    Symmetry of the expansion of stent

    Full Information

    First Posted
    February 7, 2023
    Last Updated
    February 7, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05732025
    Brief Title
    Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter
    Official Title
    Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter/Hydraulic Shock Wave Lithotripsy, A Prospective, Single-center, Randomized Controlled Exploratory Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.
    Detailed Description
    Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.The current regular interventional treatment methods for coronary calcification lesions include plain balloons, non-compliant balloons, cutting balloons, etc., but the incidence of complications is high and the rate of long-term restenosis is high, and the effect is not satisfactory. Rotary atherectomy is currently the main pretreatment method for severe calcified lesions. Rotary atherectomy combined with drug-eluting stent implantation has become an important mean for the treatment of severe calcified lesions, even complex lesions, in the DES era, and has good safety and effectiveness. However, this technique is more complicated, and in order to ensure its advantages, it needs correct and meticulous operation by an experienced interventional team. Studies have shown that the use rate of rotational atherectomy in high-capacity centers is only 3% to 5%. The reasons may be related to the expensive equipment, difficult operation and unfamiliarity with new technologies. The intra-coronary electrohydraulic shock wave balloon catheter is a device that combines electrohydraulic shock wave lithotripsy with percutaneous transluminal angioplasty. After the catheter is connected to the device and energized, the micro-transmitter installed in the balloon can generate pulsed sound pressure waves to shatter the calcified plaque inside the target lesion, enabling subsequent expansion of the lesion at low pressure. SONICO-CX intracoronary electrohydraulic shock wave balloon catheter is a new type of plaque remodeling device, which can not only change the compliance of the artery, but also reduce the damage of the vessel wall. It provides a new option for doctors to better solve the problem of severe calcified lesions, and also brings more benefits to patients. This randomized trial was conducted to assess the efficacy/safety of intracoronary electrohydraulic shock wave lithotripsy versus rotational atherectomy based on optical coherence tomography (OCT) measurements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Calcified Atheroma
    Keywords
    Calcified coronary lesions, Rotary atherectomy, Electrohydraulic shock wave lithotripsy, Optical coherence tomography (OCT)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Electrohydraulic shock wave lithotripsy
    Arm Type
    Experimental
    Arm Description
    Pre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy
    Arm Title
    Rotary atherectomy
    Arm Type
    Active Comparator
    Arm Description
    Pre-treatment of severe calcified coronary lesions with Rotary atherectomy
    Intervention Type
    Device
    Intervention Name(s)
    Electrohydraulic shock wave lithotripsy
    Intervention Description
    Pre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy
    Intervention Type
    Device
    Intervention Name(s)
    Rotary atherectomy
    Intervention Description
    Pre-treatment of severe calcified coronary lesions with rotary atherectomy
    Primary Outcome Measure Information:
    Title
    Stent expansion rate using OCT
    Description
    Stent expansion rate=Minimum lumen area in the stent/(distal reference vessel area + proximal reference vessel area)*1/2
    Time Frame
    Immediately after surgery
    Secondary Outcome Measure Information:
    Title
    Angiography success rate
    Time Frame
    Immediately after surgery
    Title
    Minimum stent area (MSA) immediately after surgery
    Time Frame
    Immediately after surgery
    Title
    Minimum lumen diameter MLD immediately after operation
    Time Frame
    Immediately after surgery
    Title
    The diameter of the lumen immediately after operation
    Time Frame
    Immediately after surgery
    Title
    Obtained lumen area immediately after operation
    Time Frame
    Immediately after surgery
    Title
    Lumen acquisition rate immediately after operation
    Time Frame
    Immediately after surgery
    Title
    Incomplete apposition rate of stent
    Time Frame
    Immediately after surgery
    Title
    Symmetry of the expansion of stent
    Time Frame
    Immediately after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical Criteria: Age ≥ 18 years old Evidence of asymptomatic ischemia, stable or unstable angina Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to accept angiography, OCT examination and clinical follow-up. Angiographic Criteria: The target lesion is primary and in situ coronary artery lesion The length of the target lesion is ≤60mm, and the diameter of the target lesion is 2.5-4.0mm (visually) The stenosis rate of the target lesion diameter is ≥70%, and the doctor judges that it is necessary to implant a stent (visual inspection method) to meet one of the following: Diameter stenosis ≥ 70%, < 100% ≥50%, <70% with evidence of ischemia The lesion allows a 0.014 guidewire to pass Under multi-angle imaging conditions, calcified shadow lesions can be seen on both sides of the lesion vessel wall (the target lesion meets the definition of severe calcification) Exclusion Criteria: Clinical Criteria: Acute myocardial infarction occurred within 30 days before operation Use special balloons (chocolate balloons, scored balloons, spinous balloons, etc.) to treat lesions at the same time Troponin is greater than 5 times the upper limit of laboratory normal value within one week before operation Severe cardiac dysfunction (grade III or IV) Left ventricular ejection fraction <25% The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery Severe uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg) Severe renal failure (serum creatinine > 221 μmol/L) Preoperative hemoglobin <100g/L Obvious coagulation dysfunction (platelet count<100×109/L or INR>1.7, INR is only required for patients who have taken warfarin orally within 2 weeks before enrollment) Blood hypercoagulability diseases (such as polycythemia vera, platelet count >750×109/L, etc.) History of stroke or TIA within 3 months History of active peptic ulcer or upper gastrointestinal bleeding within 6 months The life expectancy of the patient is less than 12 months The patient has an active systemic infection The patient has a connective tissue disorder (such as Marfan syndrome) Patient is allergic to contrast material Patients undergoing heart transplantation Patients with implanted cardiac pacemakers The patient is pregnant or breastfeeding Those who have participated in clinical trials of other drugs or medical devices within one month before enrollment; Other circumstances that the investigator considers inappropriate to participate in the trial Angiographic Criteria: Unprotected left main lesion (left main visual stenosis >50%) Baseline TIMI blood flow is less than grade 3 (evaluation after pre-dilation is allowed) A stent has been implanted within 10mm of the proximal or distal end of the target lesion The target lesion is located distal to the saphenous vein or LIMA/RIMA bypass graft Aneurysm in the target vessel Angiography confirmed the presence of thrombus in the target vessel Chronic total occlusive disease Angiography confirmed the presence of severe dissection of the target lesion before hydroelectric shock wave lithotripsy (D-F type dissection (NHLBI classification) The investigator judged that the target lesion is not suitable for patients with vasodilation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Jiang, MD,PhD
    Phone
    +86-13588706891
    Email
    Jiang_jun@zju.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haibo Chen, PhD
    Phone
    +86-13777825345
    Email
    chenhaibo1030@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jian-an Wang, MD,PhD
    Organizational Affiliation
    Second Affiliated Hospital of Zhejiang University, School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter

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