At a glance
ClinicalIndex Comparison RecordN/ACompleted· 32 enrolled
Drug / intervention
LimFlow Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia
In Brief
A clinical study evaluating LimFlow System for Critical Limb Ischemia and Chronic Limb-Threatening Ischemia. Completed, enrolled 32 participants across 7 sites.
Detailed Summary
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJul 2017
Primary CompletionAug 2019
Study CompletionJan 2021
TodayJul 2026
First PostedApr 24, 2017
Enrollment StartJul 5, 2017
Primary CompletionAug 8, 2019
Study CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.2 years ago
Interventions
LimFlow Systemdevice
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.