Clinical trial NCT03068845: Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
Official title: Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stenosis of Arteriovenous Dialysis Fistula
Keywords: non-maturing arteriovenous fistula
stenosis of arteriovenous fistula
drug-eluting balloon
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore Clinical Research Institute
First posted: 2017-03-03
Enrollment: 124
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a single-centre study, where a total of 124 subjects with non-maturing arteriovenous fistula will be randomised (1:1) to either experimental or active comparator arm. Randomisation will be stratified by location of arteriovenous fistula (above versus below elbow).

Each subject will undergo fistulogram in order to assess eligibility criteria. In the event that there is more than 1 eligible stenosis, the most severe stenosis will be considered the target (study) lesion. All other lesions will be treated in the conventional manner. No coil embolisation of collaterals will be performed in the index treatment.

If the subject is allocated to the experimental arm, the target lesion will be treated with pre-dilatation with a conventional balloon before application of the drug-eluting ballon.

If the subject is allocated to the active comparator arm, the target lesion will be treated with a conventional balloon.

High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%).

All subjects will be prescribed 1 month of dual antiplatelets (aspirin and clopidogrel), followed by 5 months of aspirin.

The duration of the study is 12 months. Follow up visits include:

1. Two-weekly follow up visits in the first 3 months after intervention until the patient is deemed ready for trial cannulation.
2. At 3 months after intervention to assess primary outcome.
3. At 6 months after intervention for a fistulogram
4. At 12 months after intervention for study closure.

Eligibility criteria: Inclusion Criteria:

1. Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:

   1. Non-maturing on physical examination, or
   2. Failed initial cannulation, or
   3. Failure to achieve prescribed dialysis within prescribed time frame.
2. Stenosis (\>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
3. Successful guidewire crossing of target lesion.
4. \>= 21 years old.
5. Informed consent given.
6. Patient willing and able to return for 3 month, 6 month fistulogram and 12 month clinic follow up.

Exclusion Criteria:

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

Primary outcomes:
measure: Fistula used successfully for haemodialysis (FUSH)
timeFrame: 3 month
Secondary outcomes:
measure: Target lesion anatomic success
timeFrame: At the end of index procedure
measure: Time from intervention to first successful haemodialysis with two-needle cannulation
timeFrame: Up to 12 months
measure: Target lesion percent stenosis at 6-month fistulogram
timeFrame: At 6 months
measure: Target lesion restenosis rate at 6-month fistulogram
timeFrame: At 6 months
measure: Number of repeat interventions to target lesion at 6 months
timeFrame: At 6 months
measure: Number of repeat interventions to target lesion at 12 months
timeFrame: At 12 months
measure: Number of repeat interventions to access circuit at 6 months
timeFrame: At 6 months
measure: Number of repeat interventions to access circuit at 12 months
timeFrame: At 12 months
measure: Post intervention target lesion patency
timeFrame: Up to 12 months
measure: Post intervention access circuit primary patency
timeFrame: Up to 12 months
measure: Post intervention access circuit assisted primary patency
timeFrame: Up to 12 months
measure: Post-intervention access circuit secondary patency
timeFrame: Up to 12 months
measure: Complication rates
timeFrame: At 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Singapore General Hospital
name: Kun Da Zhuang, FRCR, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.