Prospective Observational Single Arm study aimed to assess safety and effectiveness of APERTO OTW DCB in treating stenosis and restenosis of central veins in dialysis patients
The APERTO CVS PMCF study is aimed to evaluate safety and effectiveness of treatment of central veins (re)stenosis in dialysis patients at short and mid-term follow up, after treatment with APERTO OTW DCB. Primary endpoint will consist in evaluating the intervention free period for patients treated with APERTO OTW. APERTO CVS PMCF Study will also collect data for post-market clinical follow up (PMCF) in a CE mark device used according to intended use
Study Type
OBSERVATIONAL
Enrollment
6
Drug Coated Balloon Angioplasty
Vivantes Klinikum
Berlin, Germany
St.Franziskus Hospital
Münster, Germany
Clinically Assessed Intervention free period at 6 months fup
clinically assessed intervention free period at 6 months (IFP) defined as dialysis access circuit with no need for clinically driven target lesion repeat intervention for symptom recurrence
Time frame: 6 months
Procedural Technical Success
Residual stenosis is no more than 30% after treatment with APERTO OTW measured by angiography
Time frame: intraoperative
Procedural Clinical Success
After the procedure, haemodialysis access function improved, dialysis function restored, and at least one dialysis session completed
Time frame: intraoperative
Procedural Surgical Success
On the basis of technical success, no major adverse events (MAE) occurred during hospitalization or treatment
Time frame: intraoperative
Major Adverse Event
include death, stroke, thrombosis, allergic reactions, and pulmonary diseases (including pulmonary edema), bleeding complication with the need of transfusion
Time frame: 12 months follow up
Fistula Flow
Flow measured with Echo Doppler measured at 6 months
Time frame: 6 months
Recirculation Rate
Recirculation rate measured at 6 months
Time frame: 6 months
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