A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP Study)

NCT04633304 | Unknown FDA Device

• 1 other identifier: STP-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

CKD Stage 3; CKD Stage 4; CKD Stage 5

Keywords

CKD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Physiologically mature endoAVF at 6 months

  6 months

Study Arms (1)

AVF

OTHER

Single arm study using primary and secondary end points as comperators between subjects.

Device: EndoAVF System for endovascular AV fistula creation

Interventions

EndoAVF System for endovascular AV fistula creation DEVICE

AV fistula creation

Also known as: WavelinQ™

AVF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female Age of at least 18 years
• CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart.
• 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.
• Currently not on hemodialysis.
• Life expectancy of at least one year
• Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula
• Willing to comply with the specified follow-up evaluations

You may not qualify if:

• Thought to need dialysis within 30 days.
• The subject is in a hypercoagulable state.
• The subject has known bleeding diathesis.
• The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator.
• Known history of active intravenous drug abuse.
• The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
• The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
• 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).

Sponsors & Collaborators

• California Institute of Renal Research: lead

Study Sites (1)

California Institute of Renal Research

Escondido, California, 92027, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 31814515 BACKGROUND

• 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.

  PMID: 31894716 BACKGROUND

• 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 Access Trial (NEAT). Am J Kidney Dis. 2017 Oct;70(4):486-497. doi: 10.1053/j.ajkd.2017.03.026. Epub 2017 Jun 14.

  PMID: 28624422 RESULT

• 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(10):1545-1551. doi: 10.1007/s00270-017-1750-x. Epub 2017 Aug 7.

  PMID: 28785804 RESULT

• 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. Epub 2019 May 8.

  PMID: 31075457 RESULT

• 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.

  PMID: 32417285 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Osman Khawar, MD

  California Institute of Renal Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osman Khawar, MD

CONTACT

7602943162; okhawar@bnmg.org

Michael Gastauer

CONTACT

8588108155; mgastauer@balboaunited.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: primary end point

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: November 18, 2020
• Study Start: December 15, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 31, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)