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

• DOI: 10.3389/fcvm.2022.1039313
• Publication Date: 2022-10-18T05:30:25Z
• Authors: 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
• Keywords: endovascular treatment; Cardiovascular Medicine; peripheral artery disease; 3. Good health; calcification; 03 medical and health sciences; 0302 clinical medicine; RC666-701; health economics; Diseases of the circulatory (Cardiovascular) system; protocol; Cardiology and Cardiovascular Medicine

Objectives Peripheral artery disease with calcification is extremely prevalent in the elderly. Due to calcification, it requires a different clinical approach than more common arteriosclerosis obliterans of lower extremity. The introduction novel technologies such as drug-coated balloon, directional atherectomy, supera and drug-eluting stent has improved prognosis these patients. This study will contribute development higher-quality evidence-based medicine for treatment by assessing quality life (QOL), effect, health economics patients calcification. Method analysis Evolution designed prospective, multicenter, observational, real-world study. From January 2021 December 2022, 600 moderate severe femoropopliteal be recruited from ten locations China. After discharge, information on demographics, history, procedure details, imaging findings, follow-up collected. Patients undergo at 1, 6, 12, 18, 24 months after operation. Technical success rate, vascular questionnaire, primary patency rate target lesion, clinically driven lesion revascularization (CD-TLR), evaluation are all included outcome measures. Conclusions helps investigate financial results various endovascular therapy modalities These actual facts may help harmonize recommendations peripheral disease. Clinical trial registration protocol was registered www.clinicaltrials.gov (registration number: NCT04716361).