NCT03189667

Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: King Abdullah International Medical Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).

Detailed description

Objectives of the Study: Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons Aim of the Study: Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs. Specific Objectives: Primary functional endpoint: Access circuit patency based on functional criteria at 12 month. Primary safety endpoint: Peri procedural complication rate Secondary endpoints: * Technical success (\<30% residual stenosis without postdilation) * Access circuit dysfunction free survival (Time to event) based on functional criteria * Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)

Conditions

• Dysfunctional Dialysis Arteriovenous Fistula

Interventions

Type	Name	Description
DEVICE	Vessel preparation with angioplasty	Vessel preparation with Pre dilatation: * All lesions to be predilated with high pressure balloons until waist is obliterated. * At least two minutes dilatation. * Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%. * Multiple lesions: * To be treated with single balloon if possible. * To be treated with multiple inflation if cannot be covered with single balloon.
DEVICE	Plain balloon angioplasty	Plain balloon angioplasty * Vessel treatment with additional Plain balloon angioplasty: * Inflation to nominal pressure for at least 1 minute. * Balloon size: similar to predilation balloon.
DEVICE	Drug coated balloon angioplasty	Lutonix® Drug Coated Balloon: The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2 μg/mm2. The key functional characteristic of the formulation is to allow for release of paclitaxel to the tissue of the vascular wall during inflation. * Inflation to nominal pressure for at least 1 minute. * Balloon size: similar to the predilation balloon. * New drug coated balloon will be required for each lesion.

Timeline

• Start date: 2017-10-15
• Primary completion: 2019-02-05
• Completion: 2019-02-05
• First posted: 2017-06-16
• Last updated: 2019-05-01

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated device study