Clincosm LogoSign in Get a demo

APERTO: RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

Sponsor
Groene Hart Ziekenhuis (Other)
Overall Status
Completed
CT.gov ID
NCT02558153
Collaborator
Archer Research (Industry)
105
Enrollment
10
Locations
2
Arms
49.1
Duration (Months)
10.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DEB, drug eluting balloon
  • Device: standard PTA
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of Aperto Paclitaxel Eluting Dilatation Catheter Compared to POBA in Dialysis Fistula
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Jul 3, 2019
Actual Study Completion Date :
Jul 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: DEB - drug eluting balloon (APERTO)

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

Device: DEB, drug eluting balloon
Percutaneous angioplasty performed with a DEB - drug eluting balloon
Other Names:
  • Paclitaxel eluting balloon

    		•
    Active Comparator: standard PTA

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

    Device: standard PTA
    Percutaneous angioplasty performed with a standard balloon
    Other Names:
  • POBA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. Clinical Success [12 months]

      improvement in haemodialysis access failure and resumption of normal dialysis for at least one dialysis session after the index procedure

    4. 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)

    5. MAE - major adverse events [12 months]

      MAE defined as: death or stroke

    6. thrombotic occlusion of target lesion [12 months]

      thrombotic occlusion of target lesion

    7. thrombotic occlusion of target hemodialysis access [12 months]

      thrombotic occlusion of target hemodialysis access

    8. Clinically driven Target Lesion Revascularization (TLR) [12 months]

      Clinically driven Target Lesion Revascularization (TLR)

    9. Clinically driven Target Shunt Revascularization (TSR) [12 months]

      Clinically driven Target Shunt Revascularization (TSR)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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.

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

    3. 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

    4. 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

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

    6. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Vlaams Brabant Belgium 3000
    2 ZNA Stuivenberg Antwerpen Belgium 2060
    3 MC Leeuwarden Leeuwarden Friesland Netherlands 8934 AD
    4 Atrium Medisch Centrum. Department of radiology Heerlen Limburg Netherlands 6419 PC
    5 Catharina ziekenhuis Eindhoven Noord-Brabant Netherlands 5623 EJ
    6 St Lucas Andreas Hospital Amsterdam Noord-Holland Netherlands 1061 AE
    7 Groene Hart Ziekenhuis Gouda ZH Netherlands 2803 HH
    8 MC Haaglanden Den Haag Zuid Holland Netherlands 2512 VA
    9 Erasmus MC Rotterdam Zuid-Holland Netherlands 3015CE
    10 UMC Groningen Groningen Netherlands 9700 RB

    Sponsors and Collaborators

    • Groene Hart Ziekenhuis
    • Archer Research

    Investigators

    • Principal Investigator: Peter MT Pattynama, MD, PhD, Groene Hart Ziekenhuis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Peter M.T. Pattynama, MD, PhD. Interventional radiologist, Groene Hart Ziekenhuis
    ClinicalTrials.gov Identifier:
    NCT02558153
    Other Study ID Numbers:
    • NL44059.058.13
    First Posted:
    Sep 23, 2015
    Last Update Posted:
    May 5, 2020
    Last Verified:
    May 1, 2020
    Keywords provided by Dr Peter M.T. Pattynama, MD, PhD. Interventional radiologist, Groene Hart Ziekenhuis
    drug eluting balloon
    percutaneous balloon angioplasty
    Additional relevant MeSH terms:
    Fistula
    Paclitaxel

    Study Results

    No Results Posted as of May 5, 2020