NCT01468974

ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System for the Treatment of Subjects With Symptomatic Claudication From Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

Conditions

• Atherosclerosis
• Peripheral Vascular Disease
• Claudication

Interventions

Type	Name	Description
DEVICE	ESPRIT BVS	Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2011-11-10
• Last updated: 2019-02-04
• Results posted: 2019-02-04

Locations

8 sites across 4 countries: Austria, Belgium, France, Germany