NCT00515346

Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.

Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: VIVA Physicians · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and performance of the Xpert(TM) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the treatment of documented chronic critical limb ischemia (CLI).

Detailed description

Peripheral arterial disease (PAD) of the lower extremities affects roughly 25 million Americans annually. The diabetic population is particularly prone to the most severe clinical problems associated with PAD and the amputation rate amongst such patients is elevated five-fold. It has been shown that patients who undergo amputation for PAD/CLI have a much higher mortality rate in the months that follow. Despite medical advances in the fields of pharmacology and wound care, the vast majority of patients who present with CLI will ultimately require amputation in the absence of improved blood flow. Recently, much attention has been directed towards less invasive endovascular solutions for treating patients with CLI. This study will evaluate approximately 140 subjects with Rutherford Class IV-VI PAD in a multi-center study in order to accurately estimate limb salvage rates for this treatment.

Conditions

• Chronic Critical Limb Ischemia
• Peripheral Vascular Diseases

Interventions

Type	Name	Description
DEVICE	Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia

Timeline

• Start date: 2006-07-01
• Primary completion: 2009-12-01
• Completion: 2011-09-01
• First posted: 2007-08-13
• Last updated: 2013-12-18

Locations

1 site across 1 country: United States