FLEX Arteriovenous Access Registry

Peripheral Artery Disease Clinical Trial

Official title:

FLEX Arteriovenous Access Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070365
• Other study ID #: AV2019
• Status: Completed
• Start date: May 28, 2018
• Est. completion date: May 26, 2022

Study information

• Verified date: May 2022
• Source: VentureMed Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 26, 2022
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Stenosis
• Arteriovenous Graft Stenosis
• Constriction, Pathologic
• Fistula
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• FLEX Vessel Prep System followed by angioplasty
Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Grandview Medical Center	Birmingham	Alabama
United States	Henry Ford Health System	Detroit	Michigan
United States	Flowers Hospital	Dothan	Alabama
United States	Dialysis Access Institute	Orangeburg	South Carolina
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Richmond Vascular	Richmond	Virginia
United States	SSM Health SLU	Saint Louis	Missouri
United States	JOBST Vascular Institute	Toledo	Ohio
United States	University of Alabama	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VentureMed Group Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomic Success	Defined as the angiographic percentage of stenosis post procedure as <30%	At the completion of the index procedure
Secondary	Technical Success of the Device	Delivery to the target lesion, deployment of the treatment element, and retrieval	At the index procedure
Secondary	Clinical Success	The resumption of normal dialysis for at least one session.	6 Months
Secondary	Procedural Success	Composite of anatomic and clinical success	6 Months
Secondary	Target Lesion Primary Patency	The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion	6, 9 and 12 Months
Secondary	Circuit Primary Patency	The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.	6, 9, and Months
Secondary	Assisted Primary Patency	The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.	6, 9, and 12 Months
Secondary	Access Secondary Patency	The time interval from initial study treatment to abandonment of the vascular access circuit.	6, 9, and 12 Months