Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
NCT ID: NCT05649488
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
184 participants
INTERVENTIONAL
2023-02-09
2025-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental group
184 patients were enrolled in the experimental group
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
Optical Coherence Tomography Subgroup
70 patients in the test group were enrolled in the OCT subgroup.
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
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.
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
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.
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.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yaling Han, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Northern Theater Command
Locations
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Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
Shijiazhuang, Hebei, China
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Beijing Jishuitan Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Beijing Tsinghua Chang Gung Hospital
Beijing, , China
Tianjin Chest Hospital
Tianjin, , China
TEDA International Cardiovascular Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Jiancheng Xiu
Role: primary
Zhixiong Zhong
Role: primary
Jun Zhang
Role: primary
Leisheng Ru
Role: primary
Yan Chen
Role: primary
Xiang Cheng
Role: primary
Hong Jiang
Role: primary
Qian Tong
Role: primary
Bin Liu
Role: primary
Bo Zhang
Role: primary
Yaling Han, Ph.D
Role: primary
Shaobin Jia
Role: primary
Bin Yang
Role: primary
Ziliang BaiBai
Role: primary
Yong He
Role: primary
Wei Liu
Role: primary
Jian Liu
Role: primary
Ping Zhang
Role: primary
Qin Qin
Role: primary
Rui Jing
Role: primary
Other Identifiers
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LFBY-202201
Identifier Type: -
Identifier Source: org_study_id
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