Abbott announced the initiation of ESPRIT I, a first-of-its-kind clinical trial in Europe evaluating the safety and performance of the Esprit drug-eluting bioresorbable vascular scaffold (BVS) for the treatment of blockages in the superficial femoral arteries and iliac arteries that have resulted in claudication (leg pain upon walking).
The first patient was treated with an Esprit BVS as part of the trial by Marc Bosiers, head of the Department of Vascular Surgery at St Blasius Hospital in Dendermonde, Belgium.
The Esprit drug-eluting BVS is designed specifically for use in peripheral arteries and is made of polylactide, the same proven biocompatible material used in Abbott’s Absorb drug-eluting BVS for coronary artery disease. Absorb is authorised for sale in Europe and is investigational in the United States.
Esprit is designed to restore blood flow by opening a blocked vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the scaffold is designed to dissolve, leaving the vessel free of a permanent metallic implant. Because a permanent implant is not left behind, clinical outcomes may be improved and options for retreatment of the vessel preserved.
“Treating blockages in the super is a clinical challenge, as there are unique biomechanical forces exerted on the superficial femoral artery during normal leg movement, which can lead to restenosis or re-narrowing of the vessel,” said Johannes Lammer, professor of radiology at the Medical University of Vienna, Austria, and principal investigator for the ESPRIT I trial. “Current endovascular therapies, such as self-expanding stents and angioplasty balloons, have limitations and have not solved the problem of restenosis. A bioresorbable drug-eluting device, designed to act as a temporary scaffold to support the vessel and then fully dissolve, may change the way we treat peripheral artery disease.”
The ESPRIT I trial is a single-arm, multicentre trial designed to evaluate the safety and performance of the Esprit therapy in approximately 30 patients with claudication resulting from peripheral artery disease of the superficial femoral artery or iliac arteries. Up to 10 clinical trial sites in Europe will participate in the trial. Patients will undergo clinical haemodynamic (blood movement), functional and quality-of-life follow-up at one, six and 12 months and at two and three years following the procedure.