CKD Stage 4 Clinical Trial
Official title:
A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population
This is an investigator-initiated post-marketing study that will evaluate use of the WaveLinQ system, a new and novel method of fistula creation using a percutaneous method in patients who require the creation of an arteriovenous fistula (AVF).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or Female Age of at least 18 years 2. CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart. 3. Provide written informed consent using a form that is approved by the Institutional Review Board (IRB) prior to collection of study data or performance of study procedures. 4. Currently not on hemodialysis. 5. Life expectancy of at least one year 6. Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula 7. Willing to comply with the specified follow-up evaluations Exclusion Criteria: 1. Anatomical exclusion criteria met 2. Thought to need dialysis within 30 days. 3. The subject is in a hypercoagulable state. 4. The subject has known bleeding diathesis. 5. The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator. 6. Known history of active intravenous drug abuse. 7. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated. 8. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated. 9. Evidence of active infection on the day of the index procedure (temperature of = 38.0° Celsius and/ or WBC of = 12,000 cells/ µL, if collected). |
Country | Name | City | State |
---|---|---|---|
United States | California Institute of Renal Research | Escondido | California |
Lead Sponsor | Collaborator |
---|---|
California Institute of Renal Research |
United States,
Berland TL, Clement J, Griffin J, Westin GG, Ebner A. Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study. Ann Vasc Surg. 2019 Oct;60:182-192. doi: 10.1016/j.avsg.2019.02.023. — View Citation
Inston N, Khawaja A, Tullett K, Jones R. WavelinQ created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study. J Vasc Access. 2020 Sep;21(5):646-651. doi: 10.1177/1129729819897168. Epub 2020 Jan 2. — View Citation
Jones RG, Khawaja A, Tullett K, Inston NG. Early experience and observations in endovascular dialysis fistula re-intervention. J Vasc Access. 2020 Nov;21(6):818-825. doi: 10.1177/1129729819888374. Epub 2019 Dec 9. — View Citation
Lok CE, Rajan DK, Clement J, Kiaii M, Sidhu R, Thomson K, Buldo G, Dipchand C, Moist L, Sasal J; NEAT Investigators. Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Ac — View Citation
Radosa CG, Radosa JC, Weiss N, Schmidt C, Werth S, Hofmockel T, Plodeck V, Gatzweiler C, Laniado M, Hoffmann RT. Endovascular Creation of an Arteriovenous Fistula (endoAVF) for Hemodialysis Access: First Results. Cardiovasc Intervent Radiol. 2017 Oct;40(1 — View Citation
Zemela MS, Minami HR, Alvarez AC, Smeds MR. Real-World Usage of the WavelinQ EndoAVF System. Ann Vasc Surg. 2021 Jan;70:116-122. doi: 10.1016/j.avsg.2020.05.006. Epub 2020 May 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure Success | Successful endoAVF creation confirmed by intraprocedural angiography or duplex Ultrasound post procedure | Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks | |
Secondary | Physiologically mature endoAVF at 6 months | Percent of patients who did not require any intervention to be undertaken to maintain or re-establish patency | 6 months |
Status | Clinical Trial | Phase | |
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