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

NCT03189667 | Terminated DMC FDA Device

• 1 other identifier: RC16/035/R
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysfunctional Dialysis Arteriovenous Fistula

Outcome Measures

Primary Outcomes (1)

• AVF circuit patency

  Dialysis adequacy to be assessed based on functional criteria

  12 month

Secondary Outcomes (4)

• Technical success

  intra procedural

• Access circuit dysfunction free survival

  12 month

• Target lesion restenosis free survival

  12 month

• Number of participants with treatment-related adverse events

  12 month following the procedure

Study Arms (2)

Drug coated balloon angioplasty

EXPERIMENTAL

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

Device: Vessel preparation with angioplasty; Device: Drug coated balloon angioplasty

Plain balloon angioplasty

ACTIVE COMPARATOR

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

Device: Vessel preparation with angioplasty; Device: Plain balloon angioplasty

Interventions

Vessel preparation with angioplasty 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; Plain balloon angioplasty

Plain balloon angioplasty 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.

Plain balloon angioplasty

Drug coated balloon angioplasty 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.

Drug coated balloon angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

King ABdulaziz Medical City

Riyadh, 11426, Saudi Arabia

Location

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Mohammad Arabi, MD

  King Abdulaziz Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label randomized clinical trial

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 16, 2017
• Study Start: October 15, 2017
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)