Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery
ObjectivesPeripheral artery disease with calcification is extremely prevalent in the elderly. Due to the calcification, it requires a different clinical approach than the more common arteriosclerosis obliterans of the lower extremity. The introduction of novel technologies such as the drug-coated ba...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-10-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1039313/full |
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| author | Jun Pan Lianrui Guo Xin Fang Zibo Feng Qiang Li Chunshui He Hongfei Sang Weihao Shi Zhenyu Shi Bing Wang Chenyang Qiu Ziheng Wu Meng Ye |
| author_facet | Jun Pan Lianrui Guo Xin Fang Zibo Feng Qiang Li Chunshui He Hongfei Sang Weihao Shi Zhenyu Shi Bing Wang Chenyang Qiu Ziheng Wu Meng Ye |
| author_sort | Jun Pan |
| collection | DOAJ |
| description | ObjectivesPeripheral artery disease with calcification is extremely prevalent in the elderly. Due to the calcification, it requires a different clinical approach than the more common arteriosclerosis obliterans of the lower extremity. The introduction of novel technologies such as the drug-coated balloon, directional atherectomy, supera and drug-eluting stent has improved the prognosis of these patients. This study will contribute to the development of higher-quality evidence-based medicine for clinical treatment by assessing the quality of life (QOL), clinical treatment effect, and health economics of patients with calcification.Method and analysisThe Evolution study is designed as a prospective, multicenter, observational, real-world study. From January 2021 to December 2022, 600 patients with moderate to severe femoropopliteal artery calcification will be recruited from ten locations in China. After discharge, information on demographics, disease history, procedure details, imaging findings, and follow-up will be collected. Patients will undergo follow-up at 1, 6, 12, 18, and 24 months after operation. Technical success rate, vascular quality of life questionnaire, primary patency rate of the target lesion, clinically driven target lesion revascularization rate (CD-TLR), and health economics evaluation are all included as outcome measures.ConclusionsThe Evolution study helps to investigate the clinical and financial results of various endovascular therapy modalities for patients with moderate and severe femoropopliteal artery calcification. These actual facts may help to harmonize therapy recommendations for peripheral artery disease.Clinical trial registrationThe study protocol was registered at www.clinicaltrials.gov (registration number: NCT04716361). |
| first_indexed | 2024-04-11T09:26:58Z |
| format | Article |
| id | doaj.art-755b71b51250407fba47ad951311c7a1 |
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| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-11T09:26:58Z |
| publishDate | 2022-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-755b71b51250407fba47ad951311c7a12022-12-22T04:32:00ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-10-01910.3389/fcvm.2022.10393131039313Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal arteryJun Pan0Lianrui Guo1Xin Fang2Zibo Feng3Qiang Li4Chunshui He5Hongfei Sang6Weihao Shi7Zhenyu Shi8Bing Wang9Chenyang Qiu10Ziheng Wu11Meng Ye12Department of Vascular Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, ChinaDepartment of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, ChinaDepartment of Vascular Surgery, Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University, Hangzhou, ChinaDepartment of Vascular Surgery, Liyuan Hospital Affiliated Tongji Medical College of Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Vascular Surgery, Qingdao Haici Hospital Affiliated to Qingdao University, Qingdao, ChinaDepartment of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, ChinaDepartment of Vascular Surgery, School of Medicine, Huashan Hospital, Fudan University, Shanghai, ChinaDepartment of Vascular Surgery, School of Medicine, Zhongshan Hospital, Fudan University, Shanghai, ChinaDepartment of Vascular Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, ChinaDepartment of Vascular Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, ChinaDepartment of Vascular Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China0Department of Vascular Surgery, School of Medicine, Renji Hospital, Shanghai Jiaotong University, Shanghai, ChinaObjectivesPeripheral artery disease with calcification is extremely prevalent in the elderly. Due to the calcification, it requires a different clinical approach than the more common arteriosclerosis obliterans of the lower extremity. The introduction of novel technologies such as the drug-coated balloon, directional atherectomy, supera and drug-eluting stent has improved the prognosis of these patients. This study will contribute to the development of higher-quality evidence-based medicine for clinical treatment by assessing the quality of life (QOL), clinical treatment effect, and health economics of patients with calcification.Method and analysisThe Evolution study is designed as a prospective, multicenter, observational, real-world study. From January 2021 to December 2022, 600 patients with moderate to severe femoropopliteal artery calcification will be recruited from ten locations in China. After discharge, information on demographics, disease history, procedure details, imaging findings, and follow-up will be collected. Patients will undergo follow-up at 1, 6, 12, 18, and 24 months after operation. Technical success rate, vascular quality of life questionnaire, primary patency rate of the target lesion, clinically driven target lesion revascularization rate (CD-TLR), and health economics evaluation are all included as outcome measures.ConclusionsThe Evolution study helps to investigate the clinical and financial results of various endovascular therapy modalities for patients with moderate and severe femoropopliteal artery calcification. These actual facts may help to harmonize therapy recommendations for peripheral artery disease.Clinical trial registrationThe study protocol was registered at www.clinicaltrials.gov (registration number: NCT04716361).https://www.frontiersin.org/articles/10.3389/fcvm.2022.1039313/fullcalcificationendovascular treatmentprotocolhealth economicsperipheral artery disease |
| spellingShingle | Jun Pan Lianrui Guo Xin Fang Zibo Feng Qiang Li Chunshui He Hongfei Sang Weihao Shi Zhenyu Shi Bing Wang Chenyang Qiu Ziheng Wu Meng Ye Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery Frontiers in Cardiovascular Medicine calcification endovascular treatment protocol health economics peripheral artery disease |
| title | Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery |
| title_full | Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery |
| title_fullStr | Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery |
| title_full_unstemmed | Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery |
| title_short | Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery |
| title_sort | protocol of the evolution study a prospective multicenter observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery |
| topic | calcification endovascular treatment protocol health economics peripheral artery disease |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1039313/full |
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