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New scaffold device aims to save limbs in High-Risk patients

NCT ID NCT07465627

First seen Mar 12, 2026 · Last updated May 22, 2026 · Updated 11 times

Summary

This study tests a temporary scaffold system to open blocked leg arteries in people with chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease. The device is removed after treatment, and a drug-coated balloon is used to keep the artery open. The study focuses on high-risk patients, including those with diabetes or on dialysis, and aims to see how well the artery stays open right after the procedure. 40 participants will be followed for 12 months to check for complications like amputation or repeat procedures.

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