Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon

Phase 3

Completed

• Conditions: Arteriovenous Fistula Renal Dialysis Devices Obstruction
• Interventions: Device: PTA balloon catheter; Device: Paclitaxel-releasing PTA balloon catheter

• Registration Number: NCT02565953
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief Summary

In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. The use of these devices in venous pathology is limited. This devices could improve the treatment of renal dialysis arteriovenous fistula stenosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study Start: 2015-10
• Study First Posted: 2015-10-01
• Status Verified: 2017-03
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Patient with renal dialysis with arteriovenous fistula (AVF) at least 3 months before.
• Patient diagnosed with AVF stenosis by clinical and radiological criteria
• Sign informed consent

Exclusion Criteria

• Pregnant or breastfeeding
• Patients with AVF stenosis not could be treated with PTA catheter
• Paclitaxel allergy
• Iodinated contrast allergy
• Local or systemic active infection
• Life expectancy less than 12 moths

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTA Balloon catheter	PTA balloon catheter	Treatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter.
Paclitaxel-releasing PTA balloon catheter	Paclitaxel-releasing PTA balloon catheter	Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter.

Primary Outcome Measures

Name	Time	Method
Freedom from target lesion revascularization	12 months	Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.

Trial Locations

Locations (4)

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario Juan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital Universitario Puerto Real; 🇪🇸 Puerto Real, Cádiz, Spain