Percutaneous Deep Vein Arterialization Post-Market Study

Status: Active_not_recruiting
Location: See all (12) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 95
Healthy Volunteers: f
View:

• Subject must be \> 21 and \< 95 years of age

• Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6

• Assessment that no conventional surgical or endovascular treatment is possible

• Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be \<50% stenosed

• Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits

Locations
Other Locations
Austria
Universitätsklinikum Graz
Graz
Germany
Klinikum Arnsberg GmbH
Arnsberg
Universitätsklinikum Heidelberg
Heidelberg
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad
Universitätsklinikum Leipzig
Leipzig
St. Franziskus-Hospital GmbH
Münster
Netherlands
Jeroen Bosch Ziekenhuis
's-hertogenbosch
Noordwest Ziekenhuisgroep
Alkmaar
St. Antonius Hospital
Nieuwegein
New Zealand
Auckland City Hospital
Auckland
Singapore
Changi General Hospital
Singapore
Tan Tock Seng Hospital
Singapore
Time Frame
Start Date: 2017-12-15
Completion Date: 2025-01-24
Participants
Target number of participants: 35
Treatments
Experimental: Percutaneous deep vein arterialization
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Sponsors
Leads: LimFlow SA

This content was sourced from clinicaltrials.gov