Arteriovenous FistulaFRAMENCT04795401
The Effectiveness of FRAME FR for AVF Repair in High-Flow Reduction & Stabilization, A Prospective Trial
A study testing FRAME FR IFU in people with Arteriovenous Fistula, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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 in the arm, is considered the gold standard and first choice for vascular access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- FRAME FR IFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2021to 5 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- French speaking patient
- Patient who is affiliated to a social security system
- Patient who is able and willing to give his informed written consent.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of FRAME FR for ArterioVenous Fistula Repair in High-Flow Reduction, A Prospective, Monocenter Controlled Trial
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.
- Conditions
- Arteriovenous Fistula
- Being tested
- FRAME FR IFU
- Keywords
- Arteriovenous Fistula, Fistula reconstruction
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAME FR IFUDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FRAME Group | Experimental | 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. Receives: Device: FRAME FR IFU |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Month12
Secondary outcomes (6)
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.
Measured: at 6 and 12 months
Evaluation of the functional fistula patency
This ouctome corresponds to functional fistula patency.
Measured: at 6 and 12 months
Cardiac parameters
CPR = QA/CO ratio
Measured: at 12 months
Secondary patency
This outcome corresponds to the evaluation of thrombosis and AVF discontinuation at 6 and 12 months.
Measured: 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.
Measured: 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.
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start6 Apr 2021
- Primary completion5 Apr 2023
- Study completion5 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandros MALLIOS, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795401
- Sponsor's protocol ID
- FRAME-FR
- Acronym
- FRAME
- Status last verified
- Sep 2023
- First submitted
- 22 Feb 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of FRAME FR for ArterioVenous Fistula Repair in High-Flow Reduction, A Prospective, Monocenter Controlled Trial
- ClinicalTrials.gov ID
- NCT04795401
- Acronym / sponsor ID
- FRAME / FRAME-FR
- Conditions
- Arteriovenous Fistula
- Keywords
- Arteriovenous Fistula, Fistula reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2024 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRAME Group | Experimental | Device: FRAME FR IFUPatients 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRAME FR IFUThe surgeon will use the medical device FRAME to perform the plication procedure. The device will be selected and implanted according to the product IFU. | Device | FRAME Group |
Primary outcome
Fistula flow Evaluation M6
Time frame: Month 6
The primary outcome of the research is to evaluate the fistula flow by Doppler Us and the fistula primary patency rate over time.
Fistula flow Evaluation M12
Time frame: Month12
The primary outcome of the research is to evaluate the fistula flow by Doppler Us and the fistula primary patency rate over time
6 secondary outcomes
Occurence of safety events
Time frame: at 6 and 12 months
Evaluation of the functional fistula patency
Time frame: at 6 and 12 months
Cardiac parameters
Time frame: at 12 months
Secondary patency
Time frame: at 6 and 12 months
Patient's Quality of Life SF-36
Time frame: at 6 and 12 months
Reintervention
Time frame: at 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Amerling et al. Arteriovenous Fistula Toxicity. Blood Purif 2011; 31: 113-120.Link provided by the sponsor.
- Sheaffer et al. Minimally Invasive Limited Ligation Endoluminal-Assisted Revision (MILLER): A Review of the Available Literature and Brief Overview of Alternate Therapies in Dialysis Associated Steal Syndrome. J. Clin. Med. 2018, 7, 128.Link provided by the sponsor.
- Reddy YNV, Obokata M, Dean PG, et al. Long-term cardiovascular changes following creation of arteriovenous fistula in patients with end stage renal disease. Eur Heart J 2017; 38:1913Link provided by the sponsor.
- Basile et al. The relationship between the flow of arteriovenous fistula and cardiac output in haemodialysis patientsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandros MALLIOS, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRAME FR IFU in people with Arteriovenous Fistula, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula flow Evaluation M6 (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.