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Trial record 68 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

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

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ClinicalTrials.gov Identifier: NCT02558153
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : September 29, 2017
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)
Estimated Enrollment : 150 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
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 31, 2018

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: 6 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: 6 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: 6 months ]
    MAE defined as: death or stroke

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

  7. thrombotic occlusion of target hemodialysis access [ Time Frame: 6 months ]
    thrombotic occlusion of target hemodialysis access

  8. Clinically driven Target Lesion Revascularization (TLR) [ Time Frame: 6 months ]
    Clinically driven Target Lesion Revascularization (TLR)

  9. Clinically driven Target Shunt Revascularization (TSR) [ Time Frame: 6 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


Contacts
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Contact: Ina Kool +31 182 505196 Ina.Kool@ghz.nl
Contact: Annemiek van Mazijk +31 182 757224 Annemiek.van.Mazijk@ghz.nl

Locations
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Belgium
UZ Leuven Not yet recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Geert G Maleux, MD, PhD    +32 16 332211    geert.maleux@uzleuven.be   
Principal Investigator: Geert G Maleux, MD, PhD         
ZNA Stuivenberg Not yet recruiting
Antwerpen, Belgium, 2060
Contact: Peter P Goverde, MD    +32 3 2177481    peter.goverde@zna.be   
Principal Investigator: Peter P Goverde, MD, PhD         
Netherlands
MC Leeuwarden Recruiting
Leeuwarden, Friesland, Netherlands, 8934 AD
Contact: Johan JA Dol, MD    +31 58 2866666    j.dol@znb.nl   
Principal Investigator: Johan JA Dol, MD         
Atrium Medisch Centrum. Department of radiology Recruiting
Heerlen, Limburg, Netherlands, 6419 PC
Contact: Roel JJ Heijboer, MD    +31 45 576666    r.heijboer@atriummc.nl   
Contact    + 31 45 576666      
Principal Investigator: Roel JJ Heijboer, MD         
Catharina ziekenhuis Recruiting
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Contact: Xander AV Tielbeek, MD    '+31 40 2398565    xander.tielbeek@catherinaziekenhuis.nl   
Principal Investigator: Xander AV Tielbeek, MD, PhD         
St Lucas Andreas Hospital Recruiting
Amsterdam, Noord-Holland, Netherlands, 1061 AE
Contact: Aloys FJ Wüst, MD    +31 20 5108911    a.wust@slaz.nl   
Principal Investigator: Aloys FJ Wüst, MD         
Groene Hart Ziekenhuis Recruiting
Gouda, ZH, Netherlands, 2803 HH
Contact: Peter MT Pattynama, MD, PhD    +31 182 505050    Peter.Pattynama@ghz.nl   
Contact: Ina Kool    +31 182 505196    Ina.Kool@ghz.nl   
Principal Investigator: Peter MT Pattynama, MD, PhD         
MC Haaglanden Recruiting
Den Haag, Zuid Holland, Netherlands, 2512 VA
Contact: Edwin E. Linden, van der, MD    +31 70 3302000    e.van.der.linden@mchaaglanden.nl   
Principal Investigator: Edwin E. Linden, van der, MD, PhD         
Erasmus MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015CE
Contact: Adriaan A. Moelker, MD    +31 10 4635987    a.moelker@erasmusmc.nl   
Principal Investigator: Adriaan A. Moelker, MD, PhD         
UMC Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Job J Oldenziel, MD    + 31 50 3614260    j.oldenziel@umcg.nl   
Principal Investigator: Job J Oldenziel, MD         
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     History of Changes
Other Study ID Numbers: NL44059.058.13
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

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
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action