The Effectiveness of FRAME FR for AVF Repair in High-Flow Reduction & Stabilization, A Prospective Trial (FRAME)

  • End date
    Apr 5, 2024
  • participants needed
  • sponsor
    Groupe Hospitalier Paris Saint Joseph
Updated on 10 July 2022


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 in the arm, is considered the gold standard and first choice for vascular access. After fistula creation, the vein is subjected to high pressure and flow, and undergoes remodeling. This includes the possibility of significant dilatation and intimal hyperplasia. Normal AVF flow required for effective dialysis is around 0.6 liters/min or 0.4-0.8 liters/min. However, in at least 20% of patients, excessive remodeling and dilatation of the fistula result in a high flow AVF with >2 liters/min.

High flow fistulas significantly increase the risk for the development of high output cardiac failure, skin breakdown, bleeding, hand ischemia, and other systemic complications. In cases of high flow AVF, venous reconstruction procedures, banding and/or plication, are often required to limit venous diameter and flow. The longevity of this procedure is limited as the reconstructed segment remodels and re-dilates due to ongoing arterial pressure. Banding and plication are both procedures that are designed to increase resistance to flow. Banding is performed by wrapping a segment of polytetrafluoroethylene (PTFE) around the outflow tract of the fistula, or by placing a suture around the fistula near the arterial anastomotic area to create a narrowing. Fistula plication involves narrowing of a short segment of the proximal venous outflow tract, usually accomplished by suturing or stapling the fistula for 2-6 cm. One of the notable systemic effects of a hemodialysis AVF is an acute decrease in systemic vascular resistance with a simultaneous increase in venous return to the heart, and thus an increase of the cardiac output. Cardiac failure occurs more frequently in patients with an access flow QA>2 l/min and CPR≥20%. Another adverse systemic effect of AV fistulas is pulmonary hypertension. The increased flow volume to the heart from an AV fistula yields an increase in pulmonary pressures. This can limit pulmonary vasodilation and result in pulmonary hypertension.

Condition Arteriovenous Fistula
Treatment FRAME FR IFU
Clinical Study IdentifierNCT04795401
SponsorGroupe Hospitalier Paris Saint Joseph
Last Modified on10 July 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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