RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

Not Applicable

Completed

• Conditions: Complication of Hemodialysis; Vascular Access Complication
• Interventions: Device: standard PTA; Device: DEB, drug eluting balloon

• Registration Number: NCT02558153
• Lead Sponsor: Groene Hart Ziekenhuis

Brief Summary

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

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).

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-07
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Primary Completion: 2019-07-03
• Study Completion: 2019-07-03
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard PTA	standard PTA	Percutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug-eluting balloon (POBA, plain old balloon angioplasty).
DEB - drug eluting balloon (APERTO)	DEB, drug eluting balloon	Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting APERTO balloon

Primary Outcome Measures

Name	Time	Method
Adequate functioning of the hemodialysis access	12 months	Period of adequate functioning of the hemodialysis access after treatment, defined according to the NKF-DOQI protocol criteria

Secondary Outcome Measures

Name	Time	Method
Clinically driven Target Shunt Revascularization (TSR)	12 months	Clinically driven Target Shunt Revascularization (TSR)
Technical Success	index procedure (day 0)	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
MAE - major adverse events	12 months	MAE defined as: death or stroke
Clinical Success	12 months	improvement in haemodialysis access failure and resumption of normal dialysis for at least one dialysis session after the index procedure
thrombotic occlusion of target lesion	12 months	thrombotic occlusion of target lesion
device success	index procedure (day 0)	ability of the DEB to be delivered, inflated at pressure ≤ RBP, and retrieved from the Target Lesion without burst
Procedural Success	Index procedure (day 0)	Technical Success without the occurrence of MAE (MAE defined here as: death, stroke, thrombotic occlusion, allergic reaction, pulmonary events (including pulmonary edema)
Clinically driven Target Lesion Revascularization (TLR)	12 months	Clinically driven Target Lesion Revascularization (TLR)
thrombotic occlusion of target hemodialysis access	12 months	thrombotic occlusion of target hemodialysis access

Trial Locations

Locations (10)

UZ Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium

Atrium Medisch Centrum. Department of radiology; 🇳🇱 Heerlen, Limburg, Netherlands

St Lucas Andreas Hospital; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, ZH, Netherlands

UMC Groningen; 🇳🇱 Groningen, Netherlands

ZNA Stuivenberg; 🇧🇪 Antwerpen, Belgium

Catharina ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

MC Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands

MC Haaglanden; 🇳🇱 Den Haag, Zuid Holland, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands