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Enrollment of patients in the LIMES randomized controlled trial of balloon-coated sirolimus in BTK has begun

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News Tech: LIMES, a prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the SiroLIMus drug-coated balloon and standard angioplasty for the treatment of subpopliteal occlusion in patients with peripheral arterial disease, has already included 15 patients. patients have been enrolled, making the company a breakthrough in the treatment of peripheral arterial disease (PAD). LIMES was initiated by the University Hospital of Jena and the University Hospital of Leipzig, Germany, and the Principal Investigator (PI), Dr. Ulf Teichgräber, Co-PI Professor Thomas Zeller, and Professor Dierk Scheinert.

The patient population includes patients aged 18 years or older with documented chronic critical limb ischemia (CLI) in the affected limb, defined as the clinical Rutherford category (RCC) 4, 5, or 6. This study evaluates patients with total occlusion (100% stenosis) of the target lesion with a reference vessel diameter (RVD) of ≥2 mm and ≤4.0 mm. There is no minimum lesion length requirement, no lesion length limit, and no limit on the number of devices used. Follow-up is by internal visits at 30 days, 6, 12, 24, and 36 months.

LIMES is a prospective, multicenter, randomized controlled trial (RCT) designed to directly compare Magic Touch – PTA 0.014″ and 0.018″ (Concept Medical Inc) with his POBA (Plain Old Balloon Angioplasty) (1: 1) Evaluate. This study began with the first patient referred by Dr. PD. Nassan Malyar has been admitted to the University Hospital of Münster, Germany. The LIMES RCT plans to enroll 230 patients, who will be randomized 1:1 (Magic Touch-PTA: POBA) at currently 19 centers in Germany and Austria.

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The RCT measured the efficacy of sirolimus-coated balloons in a complex setting (CLTI) of the PAD segment (below the P3 segment of the popliteal artery to the tibiotalar joint) compared with the current standard of care, Make your research important and unique. looking forward to it. The primary endpoint of this study was a composite of limb salvage and primary patency over 6 months. In addition to the importance of the RCT, a key secondary safety endpoint is the composite of major extremity adverse events (MALE) and perioperative death (POD) at 30 days.

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