RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

NCT ID: NCT02558153

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-07-03

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).

Conditions

Complication of Hemodialysis; Vascular Access Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DEB - drug eluting balloon (APERTO)

Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting APERTO balloon

Group Type: EXPERIMENTAL

DEB, drug eluting balloon

Intervention Type: DEVICE

Percutaneous angioplasty performed with a DEB - drug eluting balloon

standard PTA

Percutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug-eluting balloon (POBA, plain old balloon angioplasty).

Group Type: ACTIVE_COMPARATOR

standard PTA

Intervention Type: DEVICE

Percutaneous angioplasty performed with a standard balloon

Interventions

DEB, drug eluting balloon

Percutaneous angioplasty performed with a DEB - drug eluting balloon

Intervention Type: DEVICE

standard PTA

Percutaneous angioplasty performed with a standard balloon

Intervention Type: DEVICE

Other Intervention Names

Paclitaxel eluting balloon; POBA

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Archer Research

INDUSTRY

Sponsor Role: collaborator

Groene Hart Ziekenhuis

OTHER

Sponsor Role: lead

Responsible Party

Dr Peter M.T. Pattynama

MD, PhD. Interventional radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter MT Pattynama, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groene Hart Ziekenhuis

Locations

UZ Leuven

Leuven, Vlaams Brabant, Belgium

ZNA Stuivenberg

Antwerp, , Belgium

Atrium Medisch Centrum. Department of radiology

Heerlen, Limburg, Netherlands

Catharina ziekenhuis

Eindhoven, North Brabant, Netherlands

St Lucas Andreas Hospital

Amsterdam, North Holland, Netherlands

MC Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Groene Hart Ziekenhuis

Gouda, South Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

MC Haaglanden

The Hague, South Holland, Netherlands

UMC Groningen

Groningen, , Netherlands

Countries

Belgium; Netherlands

Other Identifiers

NL44059.058.13

Identifier Type: -

Identifier Source: org_study_id