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

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of FRAME FR for ArterioVenous Fistula Repair in High-Flow Reduction, A Prospective, Monocenter Controlled Trial

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Device: FRAME FR IFU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FRAME Group<br>Patients will be enrolled during their hospitalization/consultation in vascular surgery department. After asking questions, his given free, informed and written consent will be collected, and recorded in his medical file by the investigator. During this hospitalization, the pre-procedure forming part of the usual care is carried out. The specific acts of research are: Cardiac echocardiography and Quality of life survey SF-36 The plication procedure will be performed according to the FRAME FR. All pre-, peri-, and post- operative routine patient management will be carried out as usual. Follow up visits will be held at 6, 12 months post procedure. All follow up visits will include the assessments as usual. The specific acts of research are as follows: Cardiac echocardiography at 12 months and quality of life survey SF-36. | Device: FRAME FR IFU<br>* The surgeon will use the medical device FRAME to perform the plication procedure. The device will be selected and implanted according to the product IFU.<br>|
| No Intervention: Control Group<br>Control group corresponds to the historical patients over a period of time sufficient to have at least 20 patients according to inclusion criteria. The information form will be sent to each patient eligible for the study by post. Without any feedback from him within 30 days, it is considered that the patient does not object to the use of its data. As part of this research, no additional examination will be performed. The data used correspond to the data collected in the usual care of patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula flow Evaluation M6 | The primary outcome of the research is to evaluate the fistula flow by Doppler Us and the fistula primary patency rate over time. | Month 6 | 
| Fistula flow Evaluation M12 | The primary outcome of the research is to evaluate the fistula flow by Doppler Us and the fistula primary patency rate over time | Month12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of safety events | This outcome corresponds to the number of safety events such as death, infection, ongoing steal, recurrent aneurysm, new cephalic arch stenosis, fistula thrombosis. | at 6 and 12 months | 
| Evaluation of the functional fistula patency | This ouctome corresponds to functional fistula patency. | at 6 and 12 months | 
| Cardiac parameters | CPR = QA/CO ratio | at 12 months | 
| Secondary patency | This outcome corresponds to the evaluation of thrombosis and AVF discontinuation at 6 and 12 months. | at 6 and 12 months | 
| Patient's Quality of Life SF-36 | The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better HRQOL. | at 6 and 12 months | 
| Reintervention | This outcome is to evaluate the number of patients who had a surgical or endovascular reintervention at 6 and 12 months. | at 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arteriovenous Fistula, Fistula reconstruction