FLEX FIRST Registry Research Protocol

Arterial Occlusive Diseases Clinical Trial

Official title:

FLEX FIRST Registry Research Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616104
• Other study ID #: VMG-2022-001
• Status: Recruiting
• Start date: November 29, 2022
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: VentureMed Group Inc.
• Contact: Jill Schweiger
• Phone: 763-296-2021
• Email: jschweiger[@]venturemedgroup.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.

Description:

Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is =18 years of age.

2. Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:

• Elevated venous pressure during hemodialysis,

• Abnormal physical findings, and

• Unexplained decrease in delivered dialysis dose.

3. Subject has a reasonable expectation of remaining on hemodialysis for =12 months.

4. Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.

5. Subject understands the study and is willing and able to comply with the follow-up requirements.

Exclusion Criteria:

1. Subject has a known or suspected systemic infection.

2. Subject has a known or suspected infection of the hemodialysis graft.

3. Subject has an untreatable allergy to radiographic contrast material.

4. In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriovenous Fistula
• Arteriovenous Graft
• Fistula

Intervention

Device:
• FLEX Vessel Prep System
The FLEX Vessel Prep System to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding Instructions for Use. Once advanced into the lesion, the balloon should be inflated according to the site's standard of care.

Locations

Country	Name	City	State
United States	Open Access Vascular Access	Miami	Florida
United States	Minneapolis Vascular Surgery Center	New Brighton	Minnesota
United States	Dialysis Access Institute	Orangeburg	South Carolina
United States	Spartanburg Regional Health	Spartanburg	South Carolina

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	Target Lesion Primary Patency Rate	Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6-months post- procedure.	6 months post procedure
Primary	Serious Adverse Event Rate	Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.	1 month