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

Primary Purpose

Coronary Artery Disease, Intravascular Lithotripsy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus
Dragonfly Opstar Imaging Catheter
Sponsored by
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southern Medical University Nanfang HospitalRecruiting
  • Meizhou People's HospitalRecruiting
  • Cangzhou Central HospitalRecruiting
  • the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
  • Fuwai Huazhong Cardiovascular Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • People's Hospital of Wuhan University
  • The First Hospital of Jilin UniversityRecruiting
  • The Second Hospital of Jilin University
  • The First Affiliated Hospital of Dalian Medical University
  • General Hospital of Northern Theater CommandRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Second Hospital of Shanxi Medical University
  • Shanxi Cardiovascular HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Beijing Jishuitan HospitalRecruiting
  • Peking University People's Hospital
  • Beijing Tsinghua Chang Gung HospitalRecruiting
  • Tianjin Chest HospitalRecruiting
  • TEDA International Cardiovascular Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Optical Coherence Tomography Subgroup

Arm Description

184 patients were enrolled in the experimental group

70 patients in the test group were enrolled in the OCT subgroup.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2022
Last Updated
April 12, 2023
Sponsor
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05649488
Brief Title
Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
September 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Intravascular Lithotripsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
184 patients were enrolled in the experimental group
Arm Title
Optical Coherence Tomography Subgroup
Arm Type
Other
Arm Description
70 patients in the test group were enrolled in the OCT subgroup.
Intervention Type
Device
Intervention Name(s)
Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Dragonfly Opstar Imaging Catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Operation success rate
Description
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
Time Frame
During hospitalization (up to 7 days after operation)
Secondary Outcome Measure Information:
Title
Angiographic success rate (residual stenosis ≤ 30%)
Description
Efficacy endpoint
Time Frame
Immediately after operation
Title
Incidence rate of MACE events 1 month and 6 months after operation
Description
Security endpoint
Time Frame
6 months after operation
Title
Target lesion failure (TLF) rate 1 month and 6 months after operation
Description
Security endpoint
Time Frame
6 months after operation
Title
Device success rate
Description
Security endpoint
Time Frame
6 months after operation
Title
Incidence of serious angiographic complications
Description
Security endpoint
Time Frame
6 months after operation
Title
Incidence rate of serious adverse events and adverse events
Description
Security endpoint
Time Frame
6 months after operation
Title
Incidence rate of device defects
Description
Security endpoint
Time Frame
6 months after operation
Other Pre-specified Outcome Measures:
Title
Minimum stent area (MSA) immediately after operation
Description
Secondary destination of OCT subgroup
Time Frame
Immediately after operation
Title
Minimum stent lumen diameter (MLD) immediately after operation
Description
Secondary destination of OCT subgroup
Time Frame
Immediately after operation
Title
Diameter of lumen obtained immediately after operation
Description
Secondary destination of OCT subgroup
Time Frame
Immediately after operation
Title
Area of lumen obtained immediately after operation
Description
Secondary destination of OCT subgroup
Time Frame
Immediately after operation
Title
Acquisition rate of lumen immediately after operation
Description
Secondary destination of OCT subgroup
Time Frame
Immediately after operation
Title
Support expansion rate
Description
Secondary destination of OCT subgroup
Time Frame
Immediately after operation
Title
Incomplete adherence rate of support beam
Description
Secondary destination of OCT subgroup
Time Frame
Immediately after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanjiao Zhang, PM
Phone
+8613889120902
Email
yanjiao.zhang@jwmsgrp.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Chang, Master
Phone
+8613701259639
Email
c.chang@jwmsgrp.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, Ph.D
Organizational Affiliation
The General Hospital of Northern Theater Command
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Medical University Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiancheng Xiu
Facility Name
Meizhou People's Hospital
City
Meizhou
State/Province
Guangdong
ZIP/Postal Code
514031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixiong Zhong
Facility Name
Cangzhou Central Hospital
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhang
Facility Name
the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050082
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leisheng Ru
Facility Name
Fuwai Huazhong Cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
451450
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Chen
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Cheng
Facility Name
People's Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Jiang
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Tong
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Liu
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Zhang
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaling Han, Ph.D
First Name & Middle Initial & Last Name & Degree
Yaling Han, Ph.D
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaobin Jia
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Yang
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030024
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziliang BaiBai
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong He
Facility Name
Beijing Jishuitan Hospital
City
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liu
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Liu
Facility Name
Beijing Tsinghua Chang Gung Hospital
City
Beijing
ZIP/Postal Code
102200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Zhang
Facility Name
Tianjin Chest Hospital
City
Tianjin
ZIP/Postal Code
300051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Qin
Facility Name
TEDA International Cardiovascular Hospital
City
Tianjin
ZIP/Postal Code
300457
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Jing

12. IPD Sharing Statement

Plan to Share IPD
No

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

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