RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

Vascular Access Complication Clinical Trial

— APERTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558153
• Other study ID #: NL44059.058.13
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 3, 2019

Study information

• Verified date: May 2020
• Source: Groene Hart Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Hemodialysis
• Fistula
• Vascular Access Complication

Intervention

Device:
• DEB, drug eluting balloon
Percutaneous angioplasty performed with a DEB - drug eluting balloon
• standard PTA
Percutaneous angioplasty performed with a standard balloon

Locations

Country	Name	City	State
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	UZ Leuven	Leuven	Vlaams Brabant
Netherlands	St Lucas Andreas Hospital	Amsterdam	Noord-Holland
Netherlands	MC Haaglanden	Den Haag	Zuid Holland
Netherlands	Catharina ziekenhuis	Eindhoven	Noord-Brabant
Netherlands	Groene Hart Ziekenhuis	Gouda	ZH
Netherlands	UMC Groningen	Groningen
Netherlands	Atrium Medisch Centrum. Department of radiology	Heerlen	Limburg
Netherlands	MC Leeuwarden	Leeuwarden	Friesland
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Groene Hart Ziekenhuis	Archer Research

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Clinical Success	improvement in haemodialysis access failure and resumption of normal dialysis for at least one dialysis session after the index procedure	12 months
Secondary	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)
Secondary	MAE - major adverse events	MAE defined as: death or stroke	12 months
Secondary	thrombotic occlusion of target lesion	thrombotic occlusion of target lesion	12 months
Secondary	thrombotic occlusion of target hemodialysis access	thrombotic occlusion of target hemodialysis access	12 months
Secondary	Clinically driven Target Lesion Revascularization (TLR)	Clinically driven Target Lesion Revascularization (TLR)	12 months
Secondary	Clinically driven Target Shunt Revascularization (TSR)	Clinically driven Target Shunt Revascularization (TSR)	12 months