Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

Conditions

Dialysis, Angioplasty

Keywords

Dialysis access, angioplasty, drug eluting balloon

Brief summary

The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.

Detailed description

In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.

Yiping Zhao, Pei Wang, Yuzhu Wang, Lihong Zhang, Yu Zhao et al. (13 authors)

Clinical Journal of the American Society of Nephrology2023-12-188 citations

10.2215/cjn.0000000000000359

Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial.

Karunanithy N, Mesa IR, Dorling A, Calder F, Katsanos K, Semik V, Robinson E, Peacock J, Das N, Forman C, Lawman S, Steiner K, Wilkins CJ, Robson MG.

2016-05-1225 citations

10.1186/s13063-016-1372-7

Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472).

Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D.

2014-12-1586 citations

10.1016/j.ejrad.2014.11.037

Interventions

DEVICEPercutaneous Transluminal Angioplasty (PTA)

Angioplasty performed with the use of the novel paclitaxel eluting balloons

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

No

Inclusion criteria

* Angiographic and clinical diagnosis of dysfunctional dialysis access due to one or more stenotic lesions. * Patients with AVF or AVG * Fistula or graft or vessel diameter ranging from 3 mm up to 12 mm

Exclusion criteria

* Fistula or graft or vessel diameter \< 3 mm and \> 12 mm * History of severe allergic reaction to contrast media * Intolerance to aspirin and/or clopidogrel * Systemic coagulopathy or hypercoagulation disorders

Design outcomes

Primary

Measure	Time frame	Description
Technical success	1 minute after the final balloon angioplasty	Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography
Primary patency	1 year	Angiographic visualization of a lesion with \<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access.

Secondary

Measure	Time frame	Description
Secondary patency	1 year	Angiographicaly proven patency (\<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access)of the treated lesion following one re-intervention procedure of any kind.
Target lesion re-intervention (TLR)-free interval	1 year	The time interval without any additional recanalization procedure within the area of the treated lesion, because of angiographic or/and clinical deterioration
Major complications rates	Periprocedural and up to 1 year	Classified according to published international guidelines and reporting standards
Minor complications rates	Periprocedural and up to 1 year follow-up	Classified according to published international guidelines and reporting standards

Countries

Greece

Outcome results

None listed