Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial

NCT03068845 | Unknown Phase 3 DMC

• 1 other identifier: ACADEMIC_01
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.

Conditions

Stenosis of Arteriovenous Dialysis Fistula

Keywords

non-maturing arteriovenous fistula; stenosis of arteriovenous fistula; drug-eluting balloon

Outcome Measures

Primary Outcomes (1)

• Fistula used successfully for haemodialysis (FUSH)

  FUSH is met if the fistula can be used with two-needle cannulation for two-thirds or more of all dialysis runs for 1 month and if it delivers the prescribed dialysis within the prescribed time frame.

  3 month

Secondary Outcomes (13)

• Target lesion anatomic success

  At the end of index procedure

• Time from intervention to first successful haemodialysis with two-needle cannulation

  Up to 12 months

• Target lesion percent stenosis at 6-month fistulogram

  At 6 months

• Target lesion restenosis rate at 6-month fistulogram

  At 6 months

• Number of repeat interventions to target lesion at 6 months

  At 6 months

Study Arms (2)

Drug-eluting Balloon Angioplasty (DEBA)

EXPERIMENTAL

After predilatation of the target lesion with conventional balloon angioplasty, a drug-eluting balloon will be inflated to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute.

Device: Drug-eluting balloon angioplasty (DEBA)

Conventional Balloon Angioplasty (CBA)

ACTIVE COMPARATOR

The target lesion will be dilated with a conventional angioplasty balloon to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute.

Device: Conventional Balloon Angioplasty (CBA)

Interventions

Drug-eluting balloon angioplasty (DEBA) DEVICE

DEBA will be performed after pre-dilatation of the target lesion for subjects allocated to the experimental arm. If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty. High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%). All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin.

Also known as: Biotronik Passeo Lux 18

Drug-eluting Balloon Angioplasty (DEBA)

Conventional Balloon Angioplasty (CBA) DEVICE

CBA will be performed for the target lesion for subjects allocated to the active comparator arm. If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty. High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%). All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin.

Also known as: Biotronik Passeo

Conventional Balloon Angioplasty (CBA)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:
• Non-maturing on physical examination, or
• Failed initial cannulation, or
• Failure to achieve prescribed dialysis within prescribed time frame.
• Stenosis (\>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
• Successful guidewire crossing of target lesion.
• \>= 21 years old.
• Informed consent given.
• Patient willing and able to return for 3 month, 6 month fistulogram and 12 month clinic follow up.

You may not qualify if:

• Thrombosed non-maturing AVF
• Target lesion is longer than 8 cm
• Previous endovascular therapy for non-maturation of the trial AVF
• Baseline systolic blood pressure less than 100 mmHg
• Non-maturing AVF is not planned to be used for dialysis in the immediate future (e.g. chronic kidney disease not requiring haemodialysis yet)
• Coagulopathy (prothrombin time or activated partial thromboplastin time \>1.5 times the median of normal range) that cannot be managed adequately with periprocedural transfusion
• Thrombocytopenia (platelet count \<50,000 /μL) that cannot be managed adequately with periprocedural transfusion
• Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication
• Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel
• Acute infection over proposed puncture site
• Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
• Men who are planning on fathering children during the study.
• Participant with medical conditions which in the opinion of the investigator may cause non-compliance with protocol.
• Currently participating in an investigational drug, biologic or device trial that may have an impact on the AVF or previous enrollment in this study.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Singapore Clinical Research Institute: collaborator

Related Publications (4)

• Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1.

  PMID: 22545894 BACKGROUND

• Lai CC, Fang HC, Tseng CJ, Liu CP, Mar GY. Percutaneous angioplasty using a paclitaxel-coated balloon improves target lesion restenosis on inflow lesions of autogenous radiocephalic fistulas: a pilot study. J Vasc Interv Radiol. 2014 Apr;25(4):535-41. doi: 10.1016/j.jvir.2013.12.014. Epub 2014 Feb 12.

  PMID: 24529550 BACKGROUND

• Manninen HI, Kaukanen E, Makinen K, Karhapaa P. Endovascular salvage of nonmaturing autogenous hemodialysis fistulas: comparison with endovascular therapy of failing mature fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):870-6. doi: 10.1016/j.jvir.2008.02.024. Epub 2008 Apr 10.

  PMID: 18503901 BACKGROUND

• Shin SW, Do YS, Choo SW, Lieu WC, Choo IW. Salvage of immature arteriovenous fistulas with percutaneous transluminal angioplasty. Cardiovasc Intervent Radiol. 2005 Jul-Aug;28(4):434-8. doi: 10.1007/s00270-003-0211-x.

  PMID: 16001144 BACKGROUND

Study Officials

• Kun Da Zhuang, FRCR, MMed

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Da Zhuang, FRCR, MMed

CONTACT

+65 62223322; zhuang.kun.da@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants, referring physicians, outcomes assessors and data analysis team will be masked. The procedurist will not be masked since it is not possible to perform the procedure without masking. The procedurist will not be involved in outcomes assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: March 3, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: March 1, 2020
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share