FLEX Arteriovenous Access Registry

Completed

• Conditions: Arteriovenous Fistula Stenosis; Peripheral Artery Disease; Arteriovenous Graft Stenosis
• Interventions: Device: FLEX Vessel Prep System followed by angioplasty

• Registration Number: NCT04070365
• Lead Sponsor: VentureMed Group Inc.

Brief Summary

Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-28
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Primary Completion: 2021-06-09
• Status Verified: 2022-05
• Study Completion: 2022-05-26
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
2. The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form.
3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
4. The patient understands the study and is willing and able to comply with follow-up requirements.
5. The patient is willing to provide informed consent.

Exclusion Criteria

1. The patient has a known or suspected systemic infection.
2. The patient has a known or suspected infection of the hemodialysis graft.
3. The patient has an untreatable allergy to radiographic contrast material.
4. In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FLEX Vessel Prep followed by angioplasty	FLEX Vessel Prep System followed by angioplasty	-

Primary Outcome Measures

Name	Time	Method
Anatomic Success	At the completion of the index procedure	Defined as the angiographic percentage of stenosis post procedure as \<30%

Secondary Outcome Measures

Name	Time	Method
Procedural Success	6 Months	Composite of anatomic and clinical success
Access Secondary Patency	6, 9, and 12 Months	The time interval from initial study treatment to abandonment of the vascular access circuit.
Technical Success of the Device	At the index procedure	Delivery to the target lesion, deployment of the treatment element, and retrieval
Clinical Success	6 Months	The resumption of normal dialysis for at least one session.
Circuit Primary Patency	6, 9, and Months	The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.
Target Lesion Primary Patency	6, 9 and 12 Months	The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion
Assisted Primary Patency	6, 9, and 12 Months	The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

Trial Locations

Locations (10)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

SSM Health SLU; 🇺🇸 Saint Louis, Missouri, United States

University of Alabama; 🇺🇸 Tuscaloosa, Alabama, United States

Richmond Vascular; 🇺🇸 Richmond, Virginia, United States

FirstHealth Moore Regional Hospital; 🇺🇸 Pinehurst, North Carolina, United States

Dialysis Access Institute; 🇺🇸 Orangeburg, South Carolina, United States

Flowers Hospital; 🇺🇸 Dothan, Alabama, United States

Grandview Medical Center; 🇺🇸 Birmingham, Alabama, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

JOBST Vascular Institute; 🇺🇸 Toledo, Ohio, United States