RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

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

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.

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:

1. Treatment Arm: paclitaxel drug-eluting balloon (DEB) dilatation using the APERTO-balloon
2. 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).

Inclusion Criteria:

All criteria 1-10 must apply for inclusion.

1. Age > 18 years and < 90 years

2. Patient or legally authorized representative providing written informed consent

3. Patient willing and likely to comply with the follow up schedule

4. 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

5. 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.

6. Target Lesion(s) is a de-novo or (non-stent) restenosis

7. 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

8. 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

9. Multiple Target Lesions are allowed per patient which can be treated by a number of APERTO DEB with aggregate max length of 160 mm

10. 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.

1. Patients unable to give informed consent
2. Patients enrolled in another study with any investigational drug or device
3. Patients previously enrolled in the APERTO trial.
4. Female patients of child bearing potential without a negative pregnancy test at the time of intervention
5. Major surgical procedures within 30 days prior to this study or planned within 30 days of entry into this study
6. Patients previously treated with a DEB in the hemodialysis access.
7. Patients with a trombosed hemodialysis access.
8. Immature hemodialysis access (unusable due to insufficient shunt flow volume)
9. Lesion treated within 30 days prior to screening
10. Failure to successfully treat non-target lesions prior the Target Lesion
11. In stent restenosis
12. Patients with any known allergy, hypersensitivity or intolerance to ASA, clopidogrel or ticlopidine, paclitaxel, or contrast medium.
13. Graft infection
14. Life expectancy < 1 years