Evaluating a new treatment for coronary artery disease using lithotripsy

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

This study is testing a new balloon treatment for people with coronary artery disease to see if it can safely break up calcium buildup in their arteries and improve their heart health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Bluesail Boyuan Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 20 sites (Guangzhou, Guangdong and 19 other locations)
• Trial ID: NCT05649488 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of an intracoronary lithotripsy balloon catheter and apparatus for treating coronary artery calcification. It will involve 184 participants who will undergo surgical treatment with these devices, followed by clinical follow-ups at 7 days, 1 month, and 6 months post-operation. The primary endpoint is the success rate of the operation, while secondary endpoints include angiographic success and major adverse cardiac events. The trial is being conducted across multiple centers in China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with symptomatic ischemia or stable/unstable angina and specific angiographic criteria.

Not a fit: Patients with non-calcified lesions or those who do not meet the angiographic inclusion criteria may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with coronary artery disease by effectively addressing calcified lesions.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating coronary artery disease with lithotripsy techniques.

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.

Where this trial is running

Guangzhou, Guangdong and 19 other locations

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

Study contacts

• Principal investigator: Yaling Han, Ph.D — The General Hospital of Northern Theater Command
• Study coordinator: Yanjiao Zhang, PM

Conditions Coronary Artery Disease; Intravascular Lithotripsy