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Trial record 1 of 1 for:    NCT02558153
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RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula (APERTO)

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ClinicalTrials.gov Identifier: NCT02558153
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Archer Research
Information provided by (Responsible Party):
Dr Peter M.T. Pattynama, 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.

Condition or disease Intervention/treatment Phase
Complication of Hemodialysis Vascular Access Complication Device: DEB, drug eluting balloon Device: standard PTA Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
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 : June 2015
Actual Primary Completion Date : July 3, 2019
Actual Study Completion Date : July 3, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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 Name: 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 Name: POBA




Primary Outcome Measures :
  1. Adequate functioning of the hemodialysis access [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
    MAE defined as: death or stroke

  6. thrombotic occlusion of target lesion [ Time Frame: 12 months ]
    thrombotic occlusion of target lesion

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

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

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



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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558153


Locations
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Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
ZNA Stuivenberg
Antwerpen, Belgium, 2060
Netherlands
MC Leeuwarden
Leeuwarden, Friesland, Netherlands, 8934 AD
Atrium Medisch Centrum. Department of radiology
Heerlen, Limburg, Netherlands, 6419 PC
Catharina ziekenhuis
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
St Lucas Andreas Hospital
Amsterdam, Noord-Holland, Netherlands, 1061 AE
Groene Hart Ziekenhuis
Gouda, ZH, Netherlands, 2803 HH
MC Haaglanden
Den Haag, Zuid Holland, Netherlands, 2512 VA
Erasmus MC
Rotterdam, Zuid-Holland, Netherlands, 3015CE
UMC Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
Groene Hart Ziekenhuis
Archer Research
Investigators
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Principal Investigator: Peter MT Pattynama, MD, PhD Groene Hart Ziekenhuis
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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: September 23, 2015    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Keywords provided by Dr Peter M.T. Pattynama, Groene Hart Ziekenhuis:
drug eluting balloon
percutaneous balloon angioplasty
Additional relevant MeSH terms:
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Fistula
Pathological Conditions, Anatomical
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action