APERTO CVS PMCF Study

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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APERTO CVS PMCF Study: Drug Coated High Pressure Balloon in Large Veins (re)Stenosis in Dialysis Patients

Conditions
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Dialysis; Complications, Central Vein Obstruction, Stenosis, Restenosis

Intervention / Treatment
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* Device: APERTO OTW DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age >18, no pregnant women, able to perform fup visits, life expectancy > 12 months Dialysis patients undergoing endovascular angioplasty due to clinically symptomatic stenosis (de novo or restenosis) of the central veins with significant (>50%) stenosis and diameter The target lesion consists of one or more lesions with a target lesion length of less than or equal to 100 mm The target blood vessel diameter of the target lesion is between 6.0 and 16.0 mm (in angiographic or ultrasound evaluation); If there are other non-target lesions, then non-target lesions must be successfully cured with a not drug coated balloon before treating the target lesion; Exclusion Criteria: Patients with CVS observed and estimated as nonsignificant (< 50% stenosis) or a vessel > 12 mm in diameter by visual estimation; the patient is now participating in another clinical trial to evaluate drug or medical device; patient enrolled for this trial before; prenatal pregnancy test result for women of childbearing potential is non-negative, Lactating woman; patients, who underwent major surgical procedures (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study; patients scheduled to undergo major surgery (eg, thoracotomy, craniotomy, etc.) within 30 days after enrolment; central veins lesions have been already treated with DCB before presence of a bare metal stent (BMS) or stent graft or vascular access thrombosis in central veins patients allergic or intolerant to paclitaxel, or contrast media; patients whose life expectancy is less than 1 year presence of Thrombus in central veins tumor compression thoracic inlet syndrome patients implanted with pacing or cardioverter devices with leads any other central line within the target lesion Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| APERTO OTW DCB<br>Dialysis patients treated with APERTO OTW following (re)stenosis of central veins | Device: APERTO OTW DCB<br>* Drug Coated Balloon Angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Technical Success | Residual stenosis is no more than 30% after treatment with APERTO OTW measured by angiography | intraoperative | 
| Procedural Clinical Success | After the procedure, haemodialysis access function improved, dialysis function restored, and at least one dialysis session completed | intraoperative | 
| Procedural Surgical Success | On the basis of technical success, no major adverse events (MAE) occurred during hospitalization or treatment | intraoperative | 
| Major Adverse Event | include death, stroke, thrombosis, allergic reactions, and pulmonary diseases (including pulmonary edema), bleeding complication with the need of transfusion | 12 months follow up | 
| Fistula Flow | Flow measured with Echo Doppler measured at 6 months | 6 months | 
| Recirculation Rate | Recirculation rate measured at 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Coated Balloon, Central Veins Stenosis, Percutaneous Intervention