Clinical trial NCT05649488: 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
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Intravascular Lithotripsy
Lead sponsor: Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Operation success rate
timeFrame: During hospitalization (up to 7 days after operation)
Secondary outcomes:
measure: Angiographic success rate (residual stenosis ≤ 30%)
timeFrame: Immediately after operation
measure: Incidence rate of MACE events 1 month and 6 months after operation
timeFrame: 6 months after operation
measure: Target lesion failure (TLF) rate 1 month and 6 months after operation
timeFrame: 6 months after operation
measure: Device success rate
timeFrame: 6 months after operation
measure: Incidence of serious angiographic complications
timeFrame: 6 months after operation
measure: Incidence rate of serious adverse events and adverse events
timeFrame: 6 months after operation
measure: Incidence rate of device defects
timeFrame: 6 months after operation
Other outcomes:
measure: Minimum stent area (MSA) immediately after operation
timeFrame: Immediately after operation
measure: Minimum stent lumen diameter (MLD) immediately after operation
timeFrame: Immediately after operation
measure: Diameter of lumen obtained immediately after operation
timeFrame: Immediately after operation
measure: Area of lumen obtained immediately after operation
timeFrame: Immediately after operation
measure: Acquisition rate of lumen immediately after operation
timeFrame: Immediately after operation
measure: Support expansion rate
timeFrame: Immediately after operation
measure: Incomplete adherence rate of support beam
timeFrame: Immediately after operation
Locations:
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital
state: Guangdong
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
state: Hebei
city: Zhengzhou
country: China
facility: Fuwai Huazhong Cardiovascular Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
state: Hubei
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
city: Tianjin
country: China
facility: Tianjin Chest Hospital
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Yaling Han, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: