NCT02690051

BeSmooth Study, Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions

BeSmooth Study, a Physician-initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the treatment of Iliac Lesions. The objective of this clinical investigation is to evaluate the long-term safety and efficacy of the BeSmooth Peripheral Stent System in clinical settings post CE-certification when used according to the indications of the IFU.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	BeSmooth peripheral stent	patients treated with the BeSmooth Peripheral Stent System

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-02-24
• Last updated: 2017-01-12

Locations

4 sites across 1 country: Belgium