Study on the effectiveness and safety of a novel intravascular shock wave balloon for pre-treatment of severe coronary artery calcification lesions
10.3969/j.issn.1004-8812.2025.02.001
- VernacularTitle:一种新型血管内冲击波球囊用于严重冠状动脉钙化病变预处理的有效性和安全性研究
- Author:
Rui-tao ZHANG
1
;
Zhen-yu TIAN
;
Yong ZENG
;
Guo-sheng FU
;
Li XU
;
Jian LIU
;
Jian-ping LI
;
Zhi-hui ZHANG
;
Xin-qun HU
;
Xiang CHENG
;
Wen LU
;
Ming CUI
;
Yi-da TANG
Author Information
1. 北京大学第三医院心血管内科,北京 100191
- Publication Type:Journal Article
- Keywords:
Coronary artery calcification;
Intravascular lithotripsy;
Prospective multicenter trial;
Vascular preparation
- From:
Chinese Journal of Interventional Cardiology
2025;33(2):61-70
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of a novel intravascular lithotripsy(IVL)balloon—Vesscrack shockwave balloon—for vascular preparation before stent implantation in patients with severe coronary artery calcification(CAC).Methods This was a prospective,single-arm,multicenter study conducted in China from June 2022 to October 2022.Patients with severe CAC were treated with the Vesscrack shockwave balloon for lesion preparation,followed by drug-eluting stent(DES)implantation.Of these,33 patients underwent optical coherence tomography(OCT).The primary endpoint was procedural success,defined as successful stent implantation with residual stenosis≤30％and the absence of in-hospital major adverse events,including cardiac death,target vessel-related myocardial infarction,or target lesion revascularization.Results A total of 170 patients[mean age:(65.9±7.9)years,116 males]were enrolled.After treatment with IVL and DES,the minimum lumen diameter increased significantly compared to baseline[(2.34±0.40)mm vs.(0.95±0.33)mm,P＜0.001],the degree of stenosis was significantly reduced[(13.24±6.60)％vs.(65.18±10.59)％,P＜0.001].Procedural success was achieved in 100％of cases,and device success was 98.8％.The 30-day patient-related cardiovascular clinical composite endpoint(POCE)rate was 0.0,with no target lesion failure,no confirmed or potential thrombotic events were observed.The shockwave energy generator demonstrated excellent stability and ease of use.Among the 33 patients assessed with OCT,after IVL intervention,the maximum calcified area of the lumen[(3.51±1.51)mm2 vs.(2.85±1.80)mm2,P＜0.001],and the minimum lumen area within the target lesion[(3.08±1.04)mm2 vs.(2.02±0.75)mm2,P＜0.001],and after DES intervention,the luminal area of the largest calcified site[(6.59±1.64)mm2 vs.(2.85±1.80)mm2,P＜0.001]and the minimum luminal area within the target lesion[(6.19±1.45)mm2 vs.(2.02±0.75)mm2,P＜0.001]were significantly increased,and the differences were statistically significant.Conclusions The Vesscrack shockwave balloon is effective and safe for vascular preparation in patients with severe CAC prior to stent implantation.It achieves significant calcified plaque modification,high procedural success rates,and minimal complications.
