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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Intravascular Lithotripsy

Intervention / Treatment
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* Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus
* Device: Dragonfly Opstar Imaging Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years, male or non-pregnant female. Evidence of symptomatic ischemia, stable or unstable angina, or MI for more than 7 days. 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 The target lesion was primary and in situ coronary artery disease. Target lesion length ≤40 mm, target lesion reference vessel diameter 2.25-4.0 mm (visual inspection). The target lesion diameter stenosis ≥70% or ≥50% (visual inspection) with evidence of ischemia. Clear, high-density shadows can be seen both when the heart is beating and when it is not. TIMI flow grade 3(allowing predilation) in the target vessel before use of the test equipment. 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. Suitable for patients undergoing metallic stent implantation Exclusion Criteria: Severe myocardial infarction occurred within 7 days before operation. 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.). NYHA Class III or IV. Left ventricular ejection fraction <35% . The target lesion was expected to be treated by fully biodegradable stent implantation, drug balloon dilatation and PTCA. Uncontrollable severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg). 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. Preoperative hemoglobin <100 g/l. Platelet count <60×109/L. Cerebral Stroke occurred within 6 months of enrollment, excluding transient ischemic attack (TIA) and lacunar infarction. A history of active peptic ulcer or upper gastrointestinal bleeding within 6 months before enrollment. Patients known to be allergic to heparin, contrast media, aspirin, clopidogrel and anesthetics. Definite diagnosis of malignancy or life expectancy would be less than 12 months. Participation in clinical trials of other drugs or medical devices that did not reach the primary end point. The researchers judged that the patients had poor compliance and could not complete the study according to the protocol. Angiographic exclusion criteria: The target lesion was in the opening position (LAD, LCX or RCA, within 5 mm of the opening) or unprotected left main coronary artery. Stents were implanted 10mm proximal or distal to the target lesion. The target lesion had unprotected branch vessels more than 2.5mm in diameter. The target lesion was distal to the saphenous vein or LIMA (Left internal mammary artery) /RIMA (Right internal mammary artery) bypass graft. Existed an aneurysm within 10mm of the target lesion. 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 The target lesion had definite thrombosis. The researchers determined that the target lesion was unsuitable for vasodilation in patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>184 patients were enrolled in the experimental group | Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus<br>* 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<br>|
| Other: Optical Coherence Tomography Subgroup<br>70 patients in the test group were enrolled in the OCT subgroup. | Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus<br>* 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<br>Device: Dragonfly Opstar Imaging Catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation success rate | 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 | During hospitalization (up to 7 days after operation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic success rate (residual stenosis ≤ 30%) | Efficacy endpoint | Immediately after operation | 
| Incidence rate of MACE events 1 month and 6 months after operation | Security endpoint | 6 months after operation | 
| Target lesion failure (TLF) rate 1 month and 6 months after operation | Security endpoint | 6 months after operation | 
| Device success rate | Security endpoint | 6 months after operation | 
| Incidence of serious angiographic complications | Security endpoint | 6 months after operation | 
| Incidence rate of serious adverse events and adverse events | Security endpoint | 6 months after operation | 
| Incidence rate of device defects | Security endpoint | 6 months after operation |