FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF) (NCT05034939) | Clinical Trial Compass
CompletedNot Applicable
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
United States75 participantsStarted 2021-09-02
Plain-language summary
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Patient is ≥21 years of age.
✓. Patient has a life expectancy of ≥12 months.
✓. Patient has a native AV fistula created ≥ 60 days prior to the index procedure.
✓. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four-week period.
✓. 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.
✓. Patient has a target lesion (which may include a tandem lesion) that is ≤ 100 mm in length (by visual estimate).
✓. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate)
✓. Patient underwent successful crossing of the target lesion with the guidewire.
Exclusion criteria
✕. Patient is pregnant or breastfeeding.
✕. Patient is receiving immunosuppressive therapy.
✕. Patient has undergone prior intervention of access site within 30 days of index procedure.
✕. Patient with anticipated conversion to peritoneal dialysis.
✕. Patient has an infected AV access or systemic infection.