In the endoscopic treatment of superficial femoral artery and/or proximal popliteal artery in patients with lower extremity arteriosclerosis occlusion, the intercalation caused by the predilation of increasing caliber balloon and matching caliber balloon was compared, and then the impact of the two predilation methods on the intraoperative treatment strategy and short and medium-term prognosis was analyzed. The study was designed as a prospective, multi-center, single-blind, randomized, controlled study. It is planned to set up 5-10 research centers with 340 subjects, and the single center will be less than or equal to 100 subjects, in the form of competition from each research center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
340
Imaging of target lesions was performed before surgery to evaluate the characteristics of target lesions. Postoperative to discharge Laboratory examination: blood routine, renal function, biochemical, coagulation functionTo determine and record the ABI(ankle-brachial pressure index);Records Rutherford classification; record the application of anticoagulant and antiplatelet agents; Records of adverse events.
Imaging of target lesions was performed before surgery to evaluate the characteristics of target lesions. Postoperative to discharge Laboratory examination: blood routine, renal function, biochemical, coagulation functionTo determine and record the ABI index;Records Rutherford classification; record the application of anticoagulant and antiplatelet agents; Records of adverse events.
Anhui Provincial Hospital
Hefei, Anhui, China
Xuanwu Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Gulou Hospital
Nanjing, Jiangsu, China
Nanjing first hospital
Nanjing, Jiangsu, China
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanxi da Hospital
Taiyuan, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
...and 1 more locations
success rate of balloon repair
During the surgery:successful conduction, accurate positioning and release, and no narrowing or blocking of the balloon. Immediately after the balloon release, angiography shows balloon patency, successful expansion of stenosis, and arteriorrhexis or dissection rupture.
Time frame: during the surgery
Balloon related adverse event rate
Renal insufficiency due to surgery; Changes in coagulation function; Degree of arterial stenosis and Degree of limb ischemia; Other adverse events
Time frame: 7 days after operation
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