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

NCT ID: NCT03189667

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-15
• Study Completion Date: 2019-02-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug coated balloon angioplasty

• Vessel preparation with Pre dilatation
• Vessel treatment with Drug-coated balloon

Group Type: EXPERIMENTAL

Vessel preparation with angioplasty

Intervention Type: DEVICE

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.

Drug coated balloon angioplasty

Intervention Type: DEVICE

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.

Plain balloon angioplasty

• Vessel preparation with Pre dilatation
• Vessel treatment with additional Plain balloon angioplasty:

Group Type: ACTIVE_COMPARATOR

Vessel preparation with angioplasty

Intervention Type: DEVICE

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.

Plain balloon angioplasty

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• >18 year old
• Dysfunctional dialysis fistula
• Radiocephalic
• Brachiocephalic
• Brachiobasilic

Clinical criteria for diagnosis of dysfunctional fistula:

• Swelling of the fistula limb
• Prolonged bleeding after withdrawing access needles
• Abnormal pulsations or weak thrill.
• Functional criteria for the diagnosis of dysfunctional criteria:
• Arteriovenous fistula is unable to deliver dialysis blood flow (Qb) of equal to or more than 300 ml/min and/or access recirculation of more than 10% on at least two occasions,
• A rising trend of venous pressure or excessive negative arterial pressure, and/or unable to deliver a Kt/v of 1.2 or more.
• Non-thrombosed

Exclusion Criteria

• Dysfunctional arteriovenous (AV) grafts
• Thrombosed fistulas
• Intra-stent stenosis
• Stenoses not responding to balloon angioplasty and requiring stenting.
• Stenosis less than 50%
• Surgical intervention that excludes the treatment segment from the access circuit
• Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure
• Location of isolated stenosis central to the thoracic inlet.
• Women who are breastfeeding, pregnant or are intending to become pregnant
• Known hypersensitivity or contraindication to contrast medium which cannot be adequately premeditated.
• Sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammad Arabi, MD

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz Medical City

Locations

King ABdulaziz Medical City

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RC16/035/R

Identifier Type: -

Identifier Source: org_study_id