FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)

Not Applicable

Completed

• Conditions: Arteriovenous Fistula Stenosis
• Interventions: Device: FLEX Vessel Prep System; Device: Angioplasty

• Registration Number: NCT05034939
• Lead Sponsor: VentureMed Group Inc.

Brief Summary

A prospective, multi-center, randomized (1:1) clinical study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) (study arm) vs PTA alone (control arm) for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.

Detailed Description

This is a prospective, multi- center, randomized (1:1) clinical study evaluating the FLEX Vessel Prep System followed with PTA (TEST arm) vs PTA alone (CONTROL arm) for the treatment of de novo or non-stented restenotic obstructive lesions up to 100 mm in length located in the arteriovenous dialysis fistulae in an upper extremity.

The objective is to evaluate and compare the serious adverse event rate at 30 days and primary patency at 6 months when using FLEX Vessel Prep System prior to PTA vs. PTA alone for treatment of obstructive lesion of native arteriovenous fistulae in the upper extremity.

Enrollment will continue until complete data sets are collected for up to 75 subjects from up to 7 sites in the US.

Study Timeline

• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study Start: 2021-09-02
• Study First Posted: 2021-09-05
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Patient is ≥21 years of age.

2. Patient has a life expectancy of ≥12 months.

3. Patient has a native AV fistula created ≥ 60 days prior to the index procedure.

4. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four-week period.

5. Patient has a de novo and/or non-stented restenotic lesion located between approximately 2 cm proximal to the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis.

6. Patient has a target lesion (which may include a tandem lesion) that is ≤ 100 mm in length (by visual estimate).

   Note: Tandem lesions may be enrolled provided they meet all of the following criteria:

   • Separated by a gap of ≤ 30mm (3 cm).
   • Total combined lesion length, including 30 mm gap, ≤ 100 mm.
   • Able to be treated as a single lesion.

7. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate)

8. Patient underwent successful crossing of the target lesion with the guidewire.

9. Patient provides written informed consent prior to enrollment in the study.

10. Patient is willing to comply with all follow-up evaluations at specified times.

Exclusion Criteria

1. Patient is pregnant or breastfeeding.
2. Patient is receiving immunosuppressive therapy.
3. Patient has undergone prior intervention of access site within 30 days of index procedure.
4. Patient with anticipated conversion to peritoneal dialysis.
5. Patient has an infected AV access or systemic infection.
6. Patient has planned surgical revision of access site.
7. Patient with secondary non-target lesion requiring treatment within 30 days post index procedure.
8. Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion.
9. Patient with target AVF or access circuit which previously had thrombectomy within last 30 days.
10. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
11. Patient with target lesion located central to the axillosubclavian junction.
12. Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access.
13. Patient has presence of pseudoaneurysm or aneurysm requiring surgical revision at the target lesion site.
14. Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated.
15. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy.
16. Patient with clinically significant Steal Syndrome requiring treatment.
17. Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint or was previously enrolled in this study.
18. Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation.
19. Patient has AV fistula created via endovascular technique.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FLEX Vessel Prep System followed with PTA (TEST arm)	FLEX Vessel Prep System	FLEX Vessel Prep System is used 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 to the lesion, the balloon should be inflated according to the site's standard of care.
PTA only (CONTROL arm)	Angioplasty	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 to the lesion, the balloon should be inflated according to the site's standard of care.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Serious Adverse Event Rate	30 Days	Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post- procedure.
Primary Efficacy Endpoint: Target Lesion Primary Patency Rate	6 Months	Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.

Secondary Outcome Measures

Name	Time	Method
Cumulative Access Circuit Thromboses Measured through 3 Months and 6 months Post-Procedure.	3 and 6 Months	Defined as proportion of subjects with access circuit thrombosis through 3 months and 6 months post-procedure.
Device Success	Procedure	Defined as successful delivery, treatment, and retrieval of the FLEX Vessel Prep device at index procedure.
Secondary Safety Endpoint: Serious Adverse Event Rate within 3 and 6 Months	3 and 6 Months	Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 3 months and 6 months post-procedure.
Access Circuit Primary Patency through 3 Months and 6 Months Post-Procedure	3 and 6 Months	Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months and 6 months post-procedure.
Target Lesion Primary Patency through 3 Months and 6 Months Post- Procedure	3 and 6 Months	Defined as freedom from CD-TLR or access thrombosis occurring in the target lesion through 3 months and 6 months post-procedure.
Cumulative Target Lesion Reinterventions Measured through 3 Months and 6 Months Post-Procedure	3 and 6 Months	Defined as proportion of subjects with TLR through 3 months and 6 months post-procedure.
Number of Interventions Required to Maintain Target Lesion Patency through 3 Months and 6 Months Post-Procedure	3 and 6 Months	Defined as number of TLR through 3 months and 6 months post-procedure.
Number of Interventions Required to Maintain Access Circuit Patency through 3 Months and 6 Months Post-Procedure	3 and 6 Months	Defined as number of reinterventions in the target lesion and/or access circuit through 3 months and 6 months post-procedure.
Clinical Success	30 Days	Defined as resumption of successful dialysis for at least one session after index procedure.
Balloon opening pressure	Procedure	Defined as minimum inflation pressure required to efface target lesion noting parallel balloon walls.
Patient Reported Pain	Procedure	Patient Reported Pain during the interventional procedure reported via Numerical Rating Scale (NRS).
Procedural Success	Procedure	Defined as maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural Serious Adverse Event (SAE).
Maximum balloon pressure	Procedure	Maximum pressure of angioplasty balloon(s) required during the interventional procedure to treat target lesion.

Trial Locations

Locations (7)

Open Access Vascular Access; 🇺🇸 Miami, Florida, United States

AKDHC Medical Research Services; 🇺🇸 Phoenix, Arizona, United States

North Carolina Nephrology; 🇺🇸 Raleigh, North Carolina, United States

Minneapolis Vascular Surgery Center; 🇺🇸 New Brighton, Minnesota, United States

Metrolina Nephrology Associates; 🇺🇸 Charlotte, North Carolina, United States

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

Dallas Nephrology Associates; 🇺🇸 Dallas, Texas, United States