A Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions: The Prospective COronary CAlcified Lesion Lithotripsy Procedure (COCALP) Study
ABSTRACT Intravascular lithotripsy (IVL) is a promising therapy for calcified coronary lesions. This study evaluated the safety and effectiveness of a novel IVL system. The COronary CAlcified Lesion Lithotripsy Procedure (COCALP) study (No. ChiCTR2300073280) was a prospective, multicenter, single‐ar...
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2025-06-01
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| Online Access: | https://doi.org/10.1002/mco2.70208 |
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| author | Xin Deng Yiqing Hu Guosheng Fu Genshan Ma Xuebo Liu Bei Shi Jianfang Luo Jingfeng Wang Zhixiong Zhong Hanbin Cui Likun Ma Juying Qian Jian'an Wang Hao Lu Junbo Ge |
| author_facet | Xin Deng Yiqing Hu Guosheng Fu Genshan Ma Xuebo Liu Bei Shi Jianfang Luo Jingfeng Wang Zhixiong Zhong Hanbin Cui Likun Ma Juying Qian Jian'an Wang Hao Lu Junbo Ge |
| author_sort | Xin Deng |
| collection | DOAJ |
| description | ABSTRACT Intravascular lithotripsy (IVL) is a promising therapy for calcified coronary lesions. This study evaluated the safety and effectiveness of a novel IVL system. The COronary CAlcified Lesion Lithotripsy Procedure (COCALP) study (No. ChiCTR2300073280) was a prospective, multicenter, single‐arm trial involving 266 patients with severely calcified coronary lesions. The primary endpoint was procedural success, defined as successful stent implantation with ≤30% residual stenosis and no in‐hospital major adverse cardiovascular events (MACE). In a subgroup, calcium morphology was evaluated by optical coherence tomography (OCT) assessment. A total of 266 patients were included. The procedural success rate was 97.4% (95% confidence interval [CI]: 0.947–0.989), with the lower limit of the CI exceeding the prespecified performance goal (p < 0.001). No MACE occurred intraoperatively. During hospitalization, MACE occurred in five patients (1.9%), all of which were myocardial infarctions. MACE rates at 1 and 6 months were 2.3 and 3.4%, respectively. In the OCT subgroup (n = 76), IVL induced a 76.8% rate of calcification fracture. The minimal lumen area increased from 1.77 ± 0.72 to 2.59 ± 1.11 mm2 following IVL (p < 0.001), and further expanded to 5.22 ± 1.69 mm2 poststenting (p < 0.001). The novel IVL system demonstrated high effectiveness and safety, supporting its use for treating severely calcified coronary lesions and enhancing stent implantation success. |
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| institution | Kabale University |
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| language | English |
| publishDate | 2025-06-01 |
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| spelling | doaj-art-3f74d5fccb844912a8395c035e7e19d42025-08-20T03:39:28ZengWileyMedComm2688-26632025-06-0166n/an/a10.1002/mco2.70208A Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions: The Prospective COronary CAlcified Lesion Lithotripsy Procedure (COCALP) StudyXin Deng0Yiqing Hu1Guosheng Fu2Genshan Ma3Xuebo Liu4Bei Shi5Jianfang Luo6Jingfeng Wang7Zhixiong Zhong8Hanbin Cui9Likun Ma10Juying Qian11Jian'an Wang12Hao Lu13Junbo Ge14State Key Laboratory of Cardiovascular Diseases Department of Cardiology Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases; National Clinical Research Center for Interventional Medicine Shanghai ChinaState Key Laboratory of Cardiovascular Diseases Department of Cardiology Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases; National Clinical Research Center for Interventional Medicine Shanghai ChinaDepartment of Cardiology Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou ChinaDepartment of Cardiology Zhongda Hospital, Southeast University School of Medicine Nanjing ChinaDepartment of Cardiology Shanghai Tongji Hospital, Tongji University School of Medicine Shanghai ChinaDepartment of Cardiology Affiliated Hospital of Zunyi Medical University Zunyi ChinaDepartment of Cardiology Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangzhou ChinaDepartment of Cardiology Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University, Guangzhou Key Laboratory of Molecular Mechanism and Translation in Major Cardiovascular Disease; Laboratory of Cardiac Electrophysiology and Arrhythmia in Guangdong Province Guangzhou ChinaCenter for Cardiovascular Diseases Meizhou People's Hospital (Huangtang Hospital), Meizhou Hospital Affiliated to Sun Yat‐sen University; Guangdong Provincial Engineering and Technology Research Center for Molecular Diagnostics of Cardiovascular Diseases; Guangdong Provincial Key Laboratory of Precision Medicine and Clinical Translational Research of Hakka Population Meizhou ChinaKey Laboratory of Precision Medicine for Atherosclerotic Diseases of Zhejiang Province, The First Affiliated Hospital of Ningbo University; Cardiology Center, The First Affiliated Hospital of Ningbo University; Ningbo Clinical Research Center for Cardiovascular Disease Ningbo ChinaDepartment of Cardiology The First Affiliated Hospital of USTC Division of Life Sciences and Medicine University of Science and Technology of China Hefei ChinaState Key Laboratory of Cardiovascular Diseases Department of Cardiology Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases; National Clinical Research Center for Interventional Medicine Shanghai ChinaDepartment of Cardiology The Second Affiliated Hospital of Zhejiang University School of Medicine, State Key Laboratory of Transvascular Implantation Devices, Heart Regeneration and Repair Key Laboratory of Zhejiang Province, Transvascular Implantation Devices Research Institute Hangzhou ChinaState Key Laboratory of Cardiovascular Diseases Department of Cardiology Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases; National Clinical Research Center for Interventional Medicine Shanghai ChinaState Key Laboratory of Cardiovascular Diseases Department of Cardiology Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases; National Clinical Research Center for Interventional Medicine Shanghai ChinaABSTRACT Intravascular lithotripsy (IVL) is a promising therapy for calcified coronary lesions. This study evaluated the safety and effectiveness of a novel IVL system. The COronary CAlcified Lesion Lithotripsy Procedure (COCALP) study (No. ChiCTR2300073280) was a prospective, multicenter, single‐arm trial involving 266 patients with severely calcified coronary lesions. The primary endpoint was procedural success, defined as successful stent implantation with ≤30% residual stenosis and no in‐hospital major adverse cardiovascular events (MACE). In a subgroup, calcium morphology was evaluated by optical coherence tomography (OCT) assessment. A total of 266 patients were included. The procedural success rate was 97.4% (95% confidence interval [CI]: 0.947–0.989), with the lower limit of the CI exceeding the prespecified performance goal (p < 0.001). No MACE occurred intraoperatively. During hospitalization, MACE occurred in five patients (1.9%), all of which were myocardial infarctions. MACE rates at 1 and 6 months were 2.3 and 3.4%, respectively. In the OCT subgroup (n = 76), IVL induced a 76.8% rate of calcification fracture. The minimal lumen area increased from 1.77 ± 0.72 to 2.59 ± 1.11 mm2 following IVL (p < 0.001), and further expanded to 5.22 ± 1.69 mm2 poststenting (p < 0.001). The novel IVL system demonstrated high effectiveness and safety, supporting its use for treating severely calcified coronary lesions and enhancing stent implantation success.https://doi.org/10.1002/mco2.70208effectivenessintravascular lithotripsymajor adverse cardiovascular eventsoptical coherence tomographysafetysevere coronary calcification |
| spellingShingle | Xin Deng Yiqing Hu Guosheng Fu Genshan Ma Xuebo Liu Bei Shi Jianfang Luo Jingfeng Wang Zhixiong Zhong Hanbin Cui Likun Ma Juying Qian Jian'an Wang Hao Lu Junbo Ge A Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions: The Prospective COronary CAlcified Lesion Lithotripsy Procedure (COCALP) Study MedComm effectiveness intravascular lithotripsy major adverse cardiovascular events optical coherence tomography safety severe coronary calcification |
| title | A Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions: The Prospective COronary CAlcified Lesion Lithotripsy Procedure (COCALP) Study |
| title_full | A Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions: The Prospective COronary CAlcified Lesion Lithotripsy Procedure (COCALP) Study |
| title_fullStr | A Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions: The Prospective COronary CAlcified Lesion Lithotripsy Procedure (COCALP) Study |
| title_full_unstemmed | A Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions: The Prospective COronary CAlcified Lesion Lithotripsy Procedure (COCALP) Study |
| title_short | A Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions: The Prospective COronary CAlcified Lesion Lithotripsy Procedure (COCALP) Study |
| title_sort | novel intravascular lithotripsy system in severely calcified coronary lesions the prospective coronary calcified lesion lithotripsy procedure cocalp study |
| topic | effectiveness intravascular lithotripsy major adverse cardiovascular events optical coherence tomography safety severe coronary calcification |
| url | https://doi.org/10.1002/mco2.70208 |
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