The purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with SUPERA stent by improving hemodynamic situation through obtuse shaping of the anastomosis.
Up to 50 patients undergoing percutaneous intervention due to juxta-anastomotic (re-)stenosis of the AV fistulas will be enrolled in this single-arm, prospective, multi-center CE marked study (IIT). Hemodialysis patients with failing radial-cephalic arteriovenous fistula (AVF) will receive treatment with the SUPERA stent and will be followed-up at 1, 3, 6 and 12 months after the procedure.
Study Type
OBSERVATIONAL
Enrollment
12
The device will be employed for treatment of juxta-anastomotic stenosis in failing AV fistula after previous percutaneous angioplasty procedures
Klinikum Hochsauerland GmbH
Arnsberg, Germany
Number of patients with primary patency of juxta-anastomose at month 3
Primary patency is defined as clinically assessed intervention free (IFP) period
Time frame: 3 months
Number of patients with primary patency of juxta-anastomose
Primary patency is defined as clinically assessed intervention free (IFP) period
Time frame: 1, 6 and 12 months.
Number of patients with assisted primary patency
Assisted primary patency is defined as interval until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access
Time frame: 1, 3, 6 and 12 months
Number of patients with secondary patency
Secondary patency is defined as interval until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to reestablish functionality in thrombosed access
Time frame: 1, 3, 6 and 12 months
Number of patients with technical success
Residual stenosis \< 30% after treatment with Supera stent (measured by angiography during the procedure)
Time frame: Day 1 after the index procedure
Number of patients with procedural success
Residual stenosis \< 30% with no major adverse events (MAE)
Time frame: 1 day (discharge)
Number of patients with clinical success
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Hemodialysis access function improved, dialysis function restored, and at least one dialysis session completed after the procedure until discharge
Time frame: 1 day (discharge)
Number of patients with access circuit patency
Freedom from development of a stenosis in any region of the AVF circuit, including the juxta-anastomotic segment
Time frame: 1,3,6,12 months
Recirculation rate
Time frame: 1, 3, 6 and 12 months
Fistula flow
Flow in AV fistula measured with ultrasound
Time frame: 1, 3, 6 and 12 months
Incidence of major adverse events
Major adverse events (death, stroke)
Time frame: 6 and 12 months