RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

Study Overview
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Brief Summary
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A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses.

Detailed Description
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Prospective multicenter randomized (1:1) Investigator Sponsored Trial, in which 150 consecutive patients candidates for percutaneous intervention of haemodialysis access will be randomly assigned to one of two study arms: Treatment Arm: paclitaxel drug-eluting balloon (DEB) dilatation using the APERTO-balloon Control Arm: standard percutaneous transluminal angioplasty (PTA). The aim is to evaluate the safety and efficacy of paclitaxel drug-eluting balloon (DEB) for the reduction of restenosis in haemodialysis shunts compared to standard percutaneous transluminal angioplasty (PTA).

Official Title
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A Randomized Trial of Aperto Paclitaxel Eluting Dilatation Catheter Compared to POBA in Dialysis Fistula

Conditions
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Complication of Hemodialysis, Vascular Access Complication

Intervention / Treatment
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* Device: DEB, drug eluting balloon
* Device: standard PTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All criteria 1-10 must apply for inclusion. Age > 18 years and < 90 years Patient or legally authorized representative providing written informed consent Patient willing and likely to comply with the follow up schedule Patients with previously well functioning hemodialysis access on the arm presenting with any of the following clinical abnormalities as defined in the NKF-DOQI-protocol criteria (National Kidney Foundation 2000): Abnormal physical examination findings (change in bruits, thrill, pulse, etc Abnormal urea recirculation measurements Elevated venous pressure during dialysis Decreased access flow Previous thrombosis in the access line Development of collateral veins Limb swelling Low arterial pressure during dialysis Unexplained decreases in dialysis dose Target Lesion is hemodynamically relevant and consists of MLD ≤ 3 mm. For enrolment this criterium is judged by the local investigator. For final analysis this criterium is based on the result of central reading of the angiogram. Target Lesion(s) is a de-novo or (non-stent) restenosis Target lesion(s) in dialysis fistulas is located at the anastomosis or in the outflow venous trajectory up to the level (but excluding) the subclavian vein Target lesion(s) in dialysis grafts is located at the arterial or venous anastomosis, inside the graft, or in the outflow venous trajectory up to the level (but excluding) the subclavian vein Multiple Target Lesions are allowed per patient which can be treated by a number of APERTO DEB with aggregate max length of 160 mm NON Target Lesions (i.e. in the subclavian vein) must be successfully treated with standard PTA prior to the Target Lesion. Exclusion Criteria: None of criteria 1-12 must apply for inclusion. Patients unable to give informed consent Patients enrolled in another study with any investigational drug or device Patients previously enrolled in the APERTO trial. Female patients of child bearing potential without a negative pregnancy test at the time of intervention Major surgical procedures within 30 days prior to this study or planned within 30 days of entry into this study Patients previously treated with a DEB in the hemodialysis access. Patients with a trombosed hemodialysis access. Immature hemodialysis access (unusable due to insufficient shunt flow volume) Lesion treated within 30 days prior to screening Failure to successfully treat non-target lesions prior the Target Lesion In stent restenosis Patients with any known allergy, hypersensitivity or intolerance to ASA, clopidogrel or ticlopidine, paclitaxel, or contrast medium. Graft infection Life expectancy < 1 years

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEB - drug eluting balloon (APERTO)<br>Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting APERTO balloon | Device: DEB, drug eluting balloon<br>* Percutaneous angioplasty performed with a DEB - drug eluting balloon<br>* Other names: Paclitaxel eluting balloon;|
| Active Comparator: standard PTA<br>Percutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug-eluting balloon (POBA, plain old balloon angioplasty). | Device: standard PTA<br>* Percutaneous angioplasty performed with a standard balloon<br>* Other names: POBA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate functioning of the hemodialysis access | Period of adequate functioning of the hemodialysis access after treatment, defined according to the NKF-DOQI protocol criteria | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device success | ability of the DEB to be delivered, inflated at pressure ≤ RBP, and retrieved from the Target Lesion without burst | index procedure (day 0) | 
| Technical Success | achievement of a lumen diameter of at least 70% of the nominal diameter of either the DEB or the post dilatation PTA balloon (whichever is bigger) by visual estimate and without bail-out stenting | index procedure (day 0) | 
| Clinical Success | improvement in haemodialysis access failure and resumption of normal dialysis for at least one dialysis session after the index procedure | 12 months | 
| Procedural Success | Technical Success without the occurrence of MAE (MAE defined here as: death, stroke, thrombotic occlusion, allergic reaction, pulmonary events (including pulmonary edema) | Index procedure (day 0) | 
| MAE - major adverse events | MAE defined as: death or stroke | 12 months | 
| thrombotic occlusion of target lesion | thrombotic occlusion of target lesion | 12 months | 
| thrombotic occlusion of target hemodialysis access | thrombotic occlusion of target hemodialysis access | 12 months | 
| Clinically driven Target Lesion Revascularization (TLR) | Clinically driven Target Lesion Revascularization (TLR) | 12 months | 
| Clinically driven Target Shunt Revascularization (TSR) | Clinically driven Target Shunt Revascularization (TSR) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon, percutaneous balloon angioplasty