Multi-center Study On the Treatment and Prognosis of Arteriosclerosis Obliterans With Different C… (NCT03725683) | Clinical Trial Compass
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Multi-center Study On the Treatment and Prognosis of Arteriosclerosis Obliterans With Different Caliber Balloon
China340 participantsStarted 2019-11-01
Plain-language summary
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.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. Target lesions from superficial femoral artery to popliteal artery P1 segment; Proximal anatomical markers of target lesions:
✓. 1cm below the fork of the common femoral artery;
✓. Distal anatomical sign of target lesions: upper border of patella;
✓. Target lesions may be single, combined, or tandem primary lesions of stenosis and/or occlusion, and meet one of the following criteria:
✓. In contrast, The stenosis rate was greater than or equal to 70% and less than 100%, and the total length of the lesions was greater than or equal to 40mm and less than or equal to 200mm.
✓. The total length of the lesion is less than 100mm.
✓. The total length of the lesion is less than or equal to 200mm, and the length of the occlusion segment is less than or equal to 100mm.
✓. The diameter of the reference vessels of target lesions shall be 4mm or more and 7mm or less.