Clinical trial NCT05034939: FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
Official title: FLEX Vessel Prep Prior to the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistula Stenosis
Lead sponsor: VentureMed Group Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Safety Endpoint: Serious Adverse Event Rate
timeFrame: 30 Days
measure: Primary Efficacy Endpoint: Target Lesion Primary Patency Rate
timeFrame: 6 Months
Secondary outcomes:
measure: Secondary Safety Endpoint: Serious Adverse Event Rate within 3 and 6 Months
timeFrame: 3 and 6 Months
measure: Access Circuit Primary Patency through 3 Months and 6 Months Post-Procedure
timeFrame: 3 and 6 Months
measure: Target Lesion Primary Patency through 3 Months and 6 Months Post- Procedure
timeFrame: 3 and 6 Months
measure: Cumulative Target Lesion Reinterventions Measured through 3 Months and 6 Months Post-Procedure
timeFrame: 3 and 6 Months
measure: Number of Interventions Required to Maintain Target Lesion Patency through 3 Months and 6 Months Post-Procedure
timeFrame: 3 and 6 Months
measure: Number of Interventions Required to Maintain Access Circuit Patency through 3 Months and 6 Months Post-Procedure
timeFrame: 3 and 6 Months
measure: Cumulative Access Circuit Thromboses Measured through 3 Months and 6 months Post-Procedure.
timeFrame: 3 and 6 Months
measure: Device Success
timeFrame: Procedure
measure: Procedural Success
timeFrame: Procedure
measure: Clinical Success
timeFrame: 30 Days
measure: Balloon opening pressure
timeFrame: Procedure
measure: Maximum balloon pressure
timeFrame: Procedure
measure: Patient Reported Pain
timeFrame: Procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AKDHC Medical Research Services
state: Arizona
city: Miami
country: United States
facility: Open Access Vascular Access
state: Florida
city: New Brighton
country: United States
facility: Minneapolis Vascular Surgery Center
state: Minnesota
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Nephrology
state: North Carolina
city: Orangeburg
country: United States
facility: Dialysis Access Institute
state: South Carolina
city: Dallas
country: United States
facility: Dallas Nephrology Associates
state: Texas
Study officials:
References: