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

NCT05649488 | Unknown DMC

• 1 other identifier: LFBY-202201
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 20

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.

Conditions

Coronary Artery Disease; Intravascular Lithotripsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Angiographic success rate (residual stenosis ≤ 30%)

  Immediately after operation

• Incidence rate of MACE events 1 month and 6 months after operation

  6 months after operation

• Target lesion failure (TLF) rate 1 month and 6 months after operation

  6 months after operation

• Device success rate

  6 months after operation

• Incidence of serious angiographic complications

  6 months after operation

Other Outcomes (7)

• Minimum stent area (MSA) immediately after operation

  Immediately after operation

• Minimum stent lumen diameter (MLD) immediately after operation

  Immediately after operation

• Diameter of lumen obtained immediately after operation

  Immediately after operation

Study Arms (2)

Experimental group

EXPERIMENTAL

184 patients were enrolled in the experimental group

Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus

Optical Coherence Tomography Subgroup

OTHER

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

Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus; Device: Dragonfly Opstar Imaging Catheter

Interventions

Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus DEVICE

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

Experimental group; Optical Coherence Tomography Subgroup

Dragonfly Opstar Imaging Catheter DEVICE

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.

Optical Coherence Tomography Subgroup

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Bluesail Boyuan Medical Technology Co., Ltd.: lead

Study Sites (20)

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, 514031, China

RECRUITING

Cangzhou Central Hospital

Cangzhou, Hebei, 061000, China

RECRUITING

the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force

Shijiazhuang, Hebei, 050082, China

NOT YET RECRUITING

Fuwai Huazhong Cardiovascular Hospital

Zhengzhou, Henan, 451450, China

NOT YET RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

People's Hospital of Wuhan University

Wuhan, Hubei, 430060, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

NOT YET RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

NOT YET RECRUITING

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 030024, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Beijing Jishuitan Hospital

Beijing, 100000, China

RECRUITING

Peking University People's Hospital

Beijing, 100044, China

NOT YET RECRUITING

Beijing Tsinghua Chang Gung Hospital

Beijing, 102200, China

RECRUITING

Tianjin Chest Hospital

Tianjin, 300051, China

RECRUITING

TEDA International Cardiovascular Hospital

Tianjin, 300457, China

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yaling Han, Ph.D

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanjiao Zhang, PM

CONTACT

+8613889120902; yanjiao.zhang@jwmsgrp.com

Ying Chang, Master

CONTACT

+8613701259639; c.chang@jwmsgrp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 14, 2022
• Study Start: February 9, 2023
• Primary Completion: December 1, 2024
• Study Completion: September 22, 2025
• Last Updated: April 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)