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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649488
• Other study ID #: LFBY-202201
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: September 22, 2025

Study information

• Verified date: December 2022
• Source: Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
• Contact: Yanjiao Zhang, PM
• Phone: +8613889120902
• Email: yanjiao.zhang[@]jwmsgrp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: September 22, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing
China	Beijing Tsinghua Chang Gung Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong
China	Meizhou People's Hospital	Meizhou	Guangdong
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force	Shijiazhuang	Hebei
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	TEDA International Cardiovascular Hospital	Tianjin
China	Tianjin Chest Hospital	Tianjin
China	People's Hospital of Wuhan University	Wuhan	Hubei
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Fuwai Huazhong Cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Minimum stent area (MSA) immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Other	Minimum stent lumen diameter (MLD) immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Other	Diameter of lumen obtained immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Other	Area of lumen obtained immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Other	Acquisition rate of lumen immediately after operation	Secondary destination of OCT subgroup	Immediately after operation
Other	Support expansion rate	Secondary destination of OCT subgroup	Immediately after operation
Other	Incomplete adherence rate of support beam	Secondary destination of OCT subgroup	Immediately after operation
Primary	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	Angiographic success rate (residual stenosis = 30%)	Efficacy endpoint	Immediately after operation
Secondary	Incidence rate of MACE events 1 month and 6 months after operation	Security endpoint	6 months after operation
Secondary	Target lesion failure (TLF) rate 1 month and 6 months after operation	Security endpoint	6 months after operation
Secondary	Device success rate	Security endpoint	6 months after operation
Secondary	Incidence of serious angiographic complications	Security endpoint	6 months after operation
Secondary	Incidence rate of serious adverse events and adverse events	Security endpoint	6 months after operation
Secondary	Incidence rate of device defects	Security endpoint	6 months after operation