IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial

This study evaluates the safety and effectiveness of a bioresorbable (biodegradable) stent called IBS Titan — which releases a medication called sirolimus to prevent re-narrowing — for treating blocked arteries below the knee in patients with critical limb ischemia (severely reduced blood flow to the foot and leg). Unlike permanent metal stents, bioresorbable stents dissolve over time, which may have long-term advantages. Adults aged 18 to 85 with confirmed critical limb ischemia and narrowing or blockage in infrapopliteal arteries (those below the knee) may be eligible, while those with severe kidney disease, active blood clotting disorders, or recent major limb surgery are excluded. Participation involves having the IBS Titan stent implanted and attending follow-up visits at 1, 6, and 12 months after the procedure. This summary was generated with AI assistance to help patients understand the study in plain language.