D001159PACHANCT05897996
Percutaneous Anastomosis Creation for Hemodialysis Access
A study testing creation of vascular access for hemodialysis in people with D001159, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The investigators propose to adult patients needing the creation of a vascular access for hemodialysis, not eligible to the creation of a distal AVF, to create a percutaneous anastomosis between an artery and a vein (endo-AVFs). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- D001159
- What is being tested?
- creation of vascular access for hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Dec 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient referred by the nephrologist for the creation of a vascular access for hemodialysis
- Patient eligible for the creation of an arteriovenous fistula of the upper limb further to assessment by the surgeon
- Pre-operative venous and arterial Doppler ultrasound performed on the upper limbs, the results of which meet the following criteria for the same limb:
- Perforating vein present and permeable, with no stenosis, measuring at least 2 mm in diameter
- Permeable cephalic vein of the arm, rectilinear over at least 10 cm, with no stenosis, measuring at least 2.5 mm
Show all 11Show fewer
- Permeable ulnar and/or radial vein, with no stenosis, measuring at least 2 mm in diameter
- Permeable ulnar and/or radial vein, with no stenosis or major calcifications, measuring at least 2 mm in diameter
- Permeable brachial artery, with no stenosis, with no major calcifications
- Informed consent signature (by the designated trusted person if necessary)
- Membership of a social security system
Who cannot join
- History of vascular access for hemodialysis on the same limb (except for a distal radiocephalic fistula with chronic malfunction or dialysis catheter)
- Patients eligible for the creation of a distal vascular access, at the anatomical snuffbox or the wrist, with the following criteria:
- Clinical examination of the upper limbs highlighting a cephalic vein at the distal 1/3 of the forearm, a radial pulse, an ulnar pulse and a negative Allen test, and
- Pre-operative venous and arterial Doppler ultrasound performed on the upper limbs, showing:
- a permeable cephalic vein on the forearm, with no stenosis, measuring at least 2 mm in diameter at the distal 1/3 of the forearm over a length of at least 15 cm.
- a permeable radial artery, with no stenosis, with no major calcifications, measuring at least 2 mm in diameter at the distal 1/3 of the forearm, not dominant,
Show all 16Show fewer
- a permeable ulnar artery, with no stenosis nor calcifications,
- a permeable palmar arch, functional, with no stenosis or calcifications
- Patients treated with immunosuppressants
- Patients having had or scheduled to have major surgery in the six weeks prior or further to inclusion
- Patients with radial arterial and/or ulnar artery thrombosis
- Patients with a vascular anomaly, including a target artery-vein distance that is too great or a venous or arterial thrombosis that is pre-existing or discovered on the day of the procedure, which does not permit use of the device.
- Patients with a severe known allergy to iodinated contrast agents
- Patients under guardianship or trusteeship
- Patients deprived of freedom
- Pregnant patients (women of child-bearing age will receive a urine pregnancy test to rule out pregnancy prior to inclusion, results will be given to them by the doctor of their choosing).
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to adult patients needing the creation of a vascular access for hemodialysis, not eligible to the creation of a distal AVF, to create a percutaneous anastomosis between an artery and a vein (endo-AVFs). The study is a prospective single-center cohort (Nice University Hospital) with a 2-year follow-up (recruitment: 18 months, length of study per patient: 24 months, data analysis: 6 months). After the procedure, patients will receive duplex-ultrasound follow-up, according to local practice, at 6 weeks (+ surgical examination), 3, 6, 12, 18 and 24 months.
Read the detailed description
- Inclusion baseline Visit The patient is adressed by his/her nephrologist for the creation of a vascular access for hemodialysis. It is provided with a venous and arterial map of the two upper limbs (not specific to the study) as well as a blood test necessary for anesthesia.
- Inclusion visit The patient is examined by the vascular surgeon who determines, via arterial and venous mapping, and once the inclusion and non-inclusion criteria have been reviewed, whether he is eligible for the study. Participation in the protocol is then proposed to him. If he agrees to participate, the patient signs the informed consent after an appropriate time for reflection. The anesthesia consultation and the date of the procedure are scheduled during this visit.
- Response: V0 The patient is hospitalized in the vascular surgery department, preferably in the day surgery unit, or in the full hospitalization department if he lives too far away or cannot be accompanied. Once in the operating room, and after anesthetic induction, the surgeon proceeds to create the percutaneous fistula. At the end of the intervention, the surgeon performs the shivering and the patient goes back to the service or remains for a while in the post-operative monitoring room depending on the anesthesia he has received. The patient is allowed to go home the same day for UCA patients, or the next day for patients on full hospitalization; once the surgeon has verified the presence of the thrill and the absence of signs of early ischemia, characterized or hematomas. The patient leaves with his appointment date at 6 weeks.
- Follow-up to S6: V1 The patient is seen again 6 weeks after the operation. The consultation begins with a Doppler to determine:
- Permeability of access
- The absence of venous and arterial stenosis
- The flow in the humeral artery
- The internal diameter of the vein and artery 2cm from the anastomosis
- Good distal hand perfusion The patient then sees the surgeon who proceeds:
- The presence of thrill
- The absence / presence of hematomas, lymphocele
- Signs of venous hypertension
- Signs of neurological deficit
- Vascular steal syndrome This consultation (Doppler and surgical follow-up) is done routinely for all creations of fistulas and is not specific to the study. If the vascular access is ready to be used, the surgeon indicates the possible puncture points on the map obtained from the Doppler. The date of first dialysis is noted by the nephrologist. During the first 5 sessions, the nephrologist informs: The type of needle
- Who performs the puncture
- The use of ultrasonographic guidance to perform the puncture The nephrologist completes a satisfaction questionnaire at the end of the first dialysis session (as well as at 3, 6, 12, 18 and 24 months after the access was created). This questionnaire includes 5 items: ease of vein palpation, ease of vein puncture, appearance of the arm with respect to their prior experience, quality of dialysis and their overall satisfaction.
- Monitoring at M3, M6, M12, M18 and M24: visits V2 to V6 The following visits contain a Doppler (identical to that carried out in V1 and included in the routine management of the patient) the results of which may lead to a consultation with the surgeon depending on the results.
It is recommended that vascular access flow be measured monthly. The months without Doppler, it will be measured during dialysis sessions (according to Transonic or Dialysance depending on the equipment of the dialysis center).
The frequency of the Dopplers will be adjusted if necessary in the event of reoperation and the opinion of the surgeon may be requested.
- Conditions
- D001159
- Being tested
- creation of vascular access for hemodialysis
- Keywords
- vascular access for hemodialysis, Arterio-Arterial Fistula
- Medical subject headings
- Arterio-Arterial Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creation of vascular access for hemodialysisDevice
endo-AVfs created with Wavelinq
| Study group | Role | What they receive |
|---|---|---|
| creation of vascular access for hemodialysis | Experimental | creation of vascular access for hemodialysis with percutaneous AVF creation Receives: Device: creation of vascular access for hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the maturation rate of endo-Arterio venous fistula created with Wavelinq
assessed as the ratio between the number of successful maturation of the access at 3 month and the total number of Arterio venous fistula created
Measured: at 3 months
Secondary outcomes (7)
nephrologist's satisfaction.
complete a satisfaction questionnaire
Measured: 3 months.
nephrologist's satisfaction.
complete a satisfaction questionnaire
Measured: 6 months.
nephrologist's satisfaction.
complete a satisfaction questionnaire
Measured: 12 months.
nephrologist's satisfaction.
complete a satisfaction questionnaire
Measured: 18 months.
nephrologist's satisfaction.
complete a satisfaction questionnaire
Measured: 24 months.
To assess the primary patency of Arterio venous fistula created percutaneously
defined by the length of time in months between Arterio venous fistula creation and 1) any later surgery or procedures aiming to rectify or restore Arterio venous fistula function OR 2) abandonment of the Arterio venous fistula
Measured: 1 year
To assess the primary patency of Arterio venous fistula created percutaneously
defined by the length of time in months between Arterio venous fistula creation and 1) any later surgery or procedures aiming to rectify or restore AVF function OR 2) abandonment of the Arterio venous fistula
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: difficulties with the device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D001159Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirvana SADAGHIANLOO, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897996
- Sponsor's protocol ID
- 21-PP-22
- Other IDs
- 2022-A01847-36
- Acronym
- PACHA
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Anastomosis Creation for Hemodialysis Access
- ClinicalTrials.gov ID
- NCT05897996
- Acronym / sponsor ID
- PACHA / 21-PP-22
- Conditions
- D001159
- Keywords
- vascular access for hemodialysis, Arterio-Arterial Fistula
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulties with the device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jun 2023 (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.
The investigators propose to adult patients needing the creation of a vascular access for hemodialysis, not eligible to the creation of a distal AVF, to create a percutaneous anastomosis between an artery and a vein (endo-AVFs). The study is a prospective single-center cohort (Nice University Hospital) with a 2-year follow-up (recruitment: 18 months, length of study per patient: 24 months, data analysis: 6 months). After the procedure, patients will receive duplex-ultrasound follow-up, according to local practice, at 6 weeks (+ surgical examination), 3, 6, 12, 18 and 24 months.
Detailed description
- Inclusion baseline Visit The patient is adressed by his/her nephrologist for the creation of a vascular access for hemodialysis. It is provided with a venous and arterial map of the two upper limbs (not specific to the study) as well as a blood test necessary for anesthesia.
- Inclusion visit The patient is examined by the vascular surgeon who determines, via arterial and venous mapping, and once the inclusion and non-inclusion criteria have been reviewed, whether he is eligible for the study. Participation in the protocol is then proposed to him. If he agrees to participate, the patient signs the informed consent after an appropriate time for reflection. The anesthesia consultation and the date of the procedure are scheduled during this visit.
- Response: V0 The patient is hospitalized in the vascular surgery department, preferably in the day surgery unit, or in the full hospitalization department if he lives too far away or cannot be accompanied. Once in the operating room, and after anesthetic induction, the surgeon proceeds to create the percutaneous fistula. At the end of the intervention, the surgeon performs the shivering and the patient goes back to the service or remains for a while in the post-operative monitoring room depending on the anesthesia he has received. The patient is allowed to go home the same day for UCA patients, or the next day for patients on full hospitalization; once the surgeon has verified the presence of the thrill and the absence of signs of early ischemia, characterized or hematomas. The patient leaves with his appointment date at 6 weeks.
- Follow-up to S6: V1 The patient is seen again 6 weeks after the operation. The consultation begins with a Doppler to determine:
- Permeability of access
- The absence of venous and arterial stenosis
- The flow in the humeral artery
- The internal diameter of the vein and artery 2cm from the anastomosis
- Good distal hand perfusion The patient then sees the surgeon who proceeds:
- The presence of thrill
- The absence / presence of hematomas, lymphocele
- Signs of venous hypertension
- Signs of neurological deficit
- Vascular steal syndrome This consultation (Doppler and surgical follow-up) is done routinely for all creations of fistulas and is not specific to the study. If the vascular access is ready to be used, the surgeon indicates the possible puncture points on the map obtained from the Doppler. The date of first dialysis is noted by the nephrologist. During the first 5 sessions, the nephrologist informs: The type of needle
- Who performs the puncture
- The use of ultrasonographic guidance to perform the puncture The nephrologist completes a satisfaction questionnaire at the end of the first dialysis session (as well as at 3, 6, 12, 18 and 24 months after the access was created). This questionnaire includes 5 items: ease of vein palpation, ease of vein puncture, appearance of the arm with respect to their prior experience, quality of dialysis and their overall satisfaction.
- Monitoring at M3, M6, M12, M18 and M24: visits V2 to V6 The following visits contain a Doppler (identical to that carried out in V1 and included in the routine management of the patient) the results of which may lead to a consultation with the surgeon depending on the results.
It is recommended that vascular access flow be measured monthly. The months without Doppler, it will be measured during dialysis sessions (according to Transonic or Dialysance depending on the equipment of the dialysis center).
The frequency of the Dopplers will be adjusted if necessary in the event of reoperation and the opinion of the surgeon may be requested.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| creation of vascular access for hemodialysis | Experimental | Device: creation of vascular access for hemodialysiscreation of vascular access for hemodialysis with percutaneous AVF creation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Patient referred by the nephrologist for the creation of a vascular access for hemodialysis
- Patient eligible for the creation of an arteriovenous fistula of the upper limb further to assessment by the surgeon
- Pre-operative venous and arterial Doppler ultrasound performed on the upper limbs, the results of which meet the following criteria for the same limb:
- Informed consent signature (by the designated trusted person if necessary)
Key exclusion criteria (16 listed)
- History of vascular access for hemodialysis on the same limb (except for a distal radiocephalic fistula with chronic malfunction or dialysis catheter)
- Patients eligible for the creation of a distal vascular access, at the anatomical snuffbox or the wrist, with the following criteria:
- Patients treated with immunosuppressants
- Patients having had or scheduled to have major surgery in the six weeks prior or further to inclusion
- Patients with radial arterial and/or ulnar artery thrombosis
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 |
|---|---|---|
| creation of vascular access for hemodialysisendo-AVfs created with Wavelinq | Device | creation of vascular access for hemodialysis |
Primary outcome
to assess the maturation rate of endo-Arterio venous fistula created with Wavelinq
Time frame: at 3 months
assessed as the ratio between the number of successful maturation of the access at 3 month and the total number of Arterio venous fistula created
7 secondary outcomes
nephrologist's satisfaction.
Time frame: 3 months.
nephrologist's satisfaction.
Time frame: 6 months.
nephrologist's satisfaction.
Time frame: 12 months.
nephrologist's satisfaction.
Time frame: 18 months.
nephrologist's satisfaction.
Time frame: 24 months.
To assess the primary patency of Arterio venous fistula created percutaneously
Time frame: 1 year
To assess the primary patency of Arterio venous fistula created percutaneously
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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.
Nirvana SADAGHIANLOO principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creation of vascular access for hemodialysis in people with D001159, run by Centre Hospitalier Universitaire de Nice 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 11 inclusion and 16 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: withdrawn, as of the sponsor's last update on 11 Jul 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
to assess the maturation rate of endo-Arterio venous fistula created with Wavelinq (time frame: at 3 months). 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 11 Jul 2025.