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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 : 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

Tracking Information
First Submitted Date  ICMJE June 7, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date September 29, 2017
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02558153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • 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
  • 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
  • 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
  • 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)
  • MAE - major adverse events [ Time Frame: 6 months ]
    MAE defined as: death or stroke
  • thrombotic occlusion of target lesion [ Time Frame: 6 months ]
    thrombotic occlusion of target lesion
  • thrombotic occlusion of target hemodialysis access [ Time Frame: 6 months ]
    thrombotic occlusion of target hemodialysis access
  • Clinically driven Target Lesion Revascularization (TLR) [ Time Frame: 6 months ]
    Clinically driven Target Lesion Revascularization (TLR)
  • Clinically driven Target Shunt Revascularization (TSR) [ Time Frame: 6 months ]
    Clinically driven Target Shunt Revascularization (TSR)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula
Official Title  ICMJE A Randomized Trial of Aperto Paclitaxel Eluting Dilatation Catheter Compared to POBA in Dialysis Fistula
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Complication of Hemodialysis
  • Vascular Access Complication
Intervention  ICMJE
  • Device: DEB, drug eluting balloon
    Percutaneous angioplasty performed with a DEB - drug eluting balloon
    Other Name: Paclitaxel eluting balloon
  • Device: standard PTA
    Percutaneous angioplasty performed with a standard balloon
    Other Name: POBA
Study Arms  ICMJE
  • Experimental: DEB - drug eluting balloon (APERTO)
    Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting APERTO balloon
    Intervention: Device: DEB, drug 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).
    Intervention: Device: standard PTA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ina Kool +31 182 505196 Ina.Kool@ghz.nl
Contact: Annemiek van Mazijk +31 182 757224 Annemiek.van.Mazijk@ghz.nl
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02558153
Other Study ID Numbers  ICMJE NL44059.058.13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Peter M.T. Pattynama, Groene Hart Ziekenhuis
Study Sponsor  ICMJE Groene Hart Ziekenhuis
Collaborators  ICMJE Archer Research
Investigators  ICMJE
Principal Investigator: Peter MT Pattynama, MD, PhD Groene Hart Ziekenhuis
PRS Account Groene Hart Ziekenhuis
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP