Peripheral Vascular Diseases Clinical Trial
Official title:
An Efficacy and Safety Study to Evaluate Ranger Drug-eluting Balloon for Below the Knee Angioplasty in Patients With Critical Limb Ischemia
Endovascular treatment of below the knee disease is a well-established therapy to improve
outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated
the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel
disease. A successful recanalization of foot artery was related to a higher ulcer healing and
a reduction of major amputation. Moreover absence of revascularization in a patient with
critical limb ischemia is an independent risk factor for mortality. Despite the introduction
of new devices dedicated to below the knee vessel disease treatment, with the development of
guides and conical balloons, long term patency outcomes are still poor. Restenosis was
observed in more than two thirds of patients within 3 months after angioplasty of tibial
arteries with a high target lesions revascularization. These re-interventions are
characterized by a higher morbidity and mortality due to several comorbidities associated to
these patients. These data confirm the need to obtain more lasting results in order to
improve long-term outcomes of these patients.
Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after
angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have
shown controversial results.
The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL
paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb
ischemia.
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