BeSmooth Study, Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions
NCT02690051 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2017-01-12
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
- DEVICE
-
BeSmooth peripheral stent
patients treated with the BeSmooth Peripheral Stent System
Sponsors & Collaborators
-
Flanders Medical Research Program
lead NETWORK
Principal Investigators
-
Koen Deloose, MD · Flanders Medical Research Program
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- Belgium
Study Locations
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