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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Intravascular Lithotripsy
• Intervention / Treatment: Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus; Device: Dragonfly Opstar Imaging Catheter

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 Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanjiao Zhang, PM; Phone Number: +8613889120902; Email: yanjiao.zhang@jwmsgrp.com
• Study Contact Backup: Name: Ying Chang, Master; Phone Number: +8613701259639; Email: c.chang@jwmsgrp.com

Study Locations

• China
  • Beijing, China, 100044
    • Not yet recruiting
    • Peking University People's Hospital
  • Beijing, China, 100000
    • Recruiting
    • Beijing Jishuitan Hospital
    • Contact: Wei Liu
  • Beijing, China, 102200
    • Recruiting
    • Beijing Tsinghua Chang Gung Hospital
    • Contact: Ping Zhang
  • Tianjin, China, 300457
    • Not yet recruiting
    • Teda International Cardiovascular Hospital
    • Contact: Rui Jing
  • Tianjin, China, 300051
    • Recruiting
    • Tianjin Chest Hospital
    • Contact: Qin Qin
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Southern Medical University Nanfang Hospital
      • Contact: Jiancheng Xiu
    • Meizhou, Guangdong, China, 514031
      • Recruiting
      • Meizhou People's Hospital
      • Contact: Zhixiong Zhong
  • Hebei
    • Cangzhou, Hebei, China, 061000
      • Recruiting
      • Cangzhou Central Hospital
      • Contact: Jun Zhang
    • Shijiazhuang, Hebei, China, 050082
      • Not yet recruiting
      • the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
      • Contact: Leisheng Ru
  • Henan
    • Zhengzhou, Henan, China, 451450
      • Not yet recruiting
      • Fuwai Huazhong Cardiovascular Hospital
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xiang Cheng
    • Wuhan, Hubei, China, 430060
      • Not yet recruiting
      • People's Hospital of Wuhan University
      • Contact: Hong Jiang
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Qian Tong
    • Changchun, Jilin, China, 130041
      • Not yet recruiting
      • The Second Hospital of Jilin University
      • Contact: Bin Liu
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • Not yet recruiting
      • The First Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • General Hospital of Northern Theater Command
      • Contact: Yaling Han, Ph.D
      • Principal Investigator: Yaling Han, Ph.D
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Shaobin Jia
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Not yet recruiting
      • Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 030024
      • Recruiting
      • Shanxi Cardiovascular Hospital
      • Contact: Ziliang BaiBai
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Yong He

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum stent area (MSA) immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Minimum stent lumen diameter (MLD) immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Diameter of lumen obtained immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Area of lumen obtained immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Acquisition rate of lumen immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Support expansion rate	Secondary destination of OCT subgroup	Immediately after operation
Incomplete adherence rate of support beam	Secondary destination of OCT subgroup	Immediately after operation

Collaborators and Investigators

• Sponsor: Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
• Investigators: Principal Investigator: Yaling Han, Ph.D, The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): September 22, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: LFBY-202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No