NCT05654103Fut, nem toboroz
Comparing Surgical and Endovascular Arteriovenous Fistula Creation
Randomized Controlled Trial Comparing endoAVF Versus surgAVF
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 10.
Rövid összefoglaló (regiszter, angolul)
Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein. Until recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF. This study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 90 (tervezett)
- Első benyújtás
- 2022. dec. 8.
- Kezdés
- 2024. nov. 20.
- Elsődleges befejezés
- 2026. okt.
- Fő szponzor
- University of California, Los Angeles
- Betegségek
- Krónikus vesebetegség
- NCT-szám
- NCT05654103
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 90
- 2024. nov. 20. és az elsődleges befejezés (2026. okt.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Individuals who choose peritoneal dialysis over hemodialysis and/or undergoing a kidney transplant within 6 months of randomization.
Életkor
- People under the age of 18.
Egyéb
- Inability to understand the consent process and/or give consent.
- Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.
- Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a forearm access is the optimal access for the patient, in order to preserve more proximal anatomic sites for future accesses.
- Currently incarcerated individuals.
- Currently pregnant or planning to get pregnant within the next 6 months.
Kiket keres a vizsgálat
- ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.
- Ability to give consent to participate in a research study.
- Upper arm vein diameter of ≥ 2.0 mm.
- Ellipsys specific inclusion criteria:
- Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed pre-procedurally.
- Confirmed radial artery and adjacent vein diameter of ≥ 2.0 mm at site where vein and artery connects.
- WavelinQ specific inclusion criteria:
- Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein.
Életkor a regiszterben: 18 év – 99 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| UCLA Division of Vascular and Endovascular Surgery Clinic | Los Angeles | Egyesült Államok | Ismeretlen állapot |
| University of Pittsburgh Medical Center | Pittsburgh | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.