Status:
UNKNOWN
The Effectiveness of FRAME FR for AVF Repair in High-Flow Reduction & Stabilization, A Prospective Trial
Lead Sponsor:
Fondation Hôpital Saint-Joseph
Conditions:
Arteriovenous Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with end-stage renal disease require permanent vascular access to enable safe and effective hemodialysis. An arteriovenous fistula (AVF), where a vein is mobilized and connected to an artery ...
Eligibility Criteria
Inclusion
- Patient aged over 18 years
- Patient with a fistula flow \>1.5l/min
- Patient with a hemodialysis AVF and heart failure symptoms and who may require a reduction in flow even if \<1.5l/min
- Patient whose AVF flows \<1.5l/min and who may require a flow reduction for a reduction of edema in case of central vein stenosis or symptom of steal syndrome
- Patient referred by a cardiologist for high output cardiac failure
- Patient who is able and willing to comply with the study follow up requirements
- French speaking patient
- Patient who is affiliated to a social security system
- Patient who is able and willing to give his informed written consent.
Exclusion
- Patient with any local near fistula or systemic sign or infection
- Patient with AV Fistula composite (constructed or prosthetic graft and vein
- Patient with stents within the operative portion of the fistula
- Patients with known central venous stenosis or occlusion
- Patients with a hand ischemia
- Patient with wall thickness \>2 mm, with separation or thrombus within the operative portion of the fistula that cannot be removed, as determined intraoperatively
- Hypercoagulability, on chronic anticoagulation
- Pregnant and breastfeeding women
- Concomitant life-threatening disease, likely to limit life expectancy to less than two years
- Inability to tolerate or comply with required guideline based upon post-operative drug regimen
- Inability to tolerate or comply with required follow-ups
- Concurrent participation in an interventional (drug or device) study for which the follow-up is not completed
- Patient unable or unwilling to perform all the requested tasks
- Patient under tutorship or curatorship
- Patient deprived of liberty.
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04795401
Start Date
April 6 2021
End Date
April 5 2024
Last Update
September 13 2023
Active Locations (1)
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1
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014