Clinical Research Directory

Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI

Sponsor: Attikon Hospital

Summary

Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis. It leads to peripheral arterial stenosis, commonly in the lower extremities, resulting in symptoms ranging from intermittent claudication to chronic limb-threatening ischemia (CLTI). Endovascular interventions are currently considered first-line treatment approaches for PAD. Laser atherectomy offers a minimally invasive endovascular option to effectively debulk atherosclerotic steno-occlusive lesions prior to balloon angioplasty, minimizing vessel dissection and the need for stenting. Additionally, recent multicenter randomized controlled trials have demonstrated that sirolimus-coated balloon (SCB) angioplasty is a safe and effective treatment method for PAD. Although safety and efficacy of both laser atherectomy and SCBs are recognized, their combination for the treatment of patients with CLTI has not been adequately investigated. This research pilot study aimed to evaluate the safety and efficacy of combined laser atherectomy and SCB angioplasty for the treatment of CLTI. Key endpoints of the study include technical success rate, major adverse events, rates of limb salvage and target lesion reintervention, clinical improvement and overall patient survival rate.

Official title: LASER Atherectomy and Sirolimus-coated Balloon Angioplasty for Chronic Limb-threatening Ischemia: The LASER-S Study

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