Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.

Study Overview

• Status: Unknown
• Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae
• Intervention / Treatment: Device: NMB Paclitaxel Drug Ejecting Balloon

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eli Atar, MD; Phone Number: 972-3-9376389; Email: elia@clalit.org.il

Study Locations

• Israel
  • Petah Tikva, Israel
    • The Rabin Medical Center, Hasharon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is 18 years old or older.
2. Native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed.
3. Patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for PTA procedure.
4. Patient who is willing and able to sign a written informed consent and that complies with procedures (including adherence to follow-up visits).

Exclusion Criteria:

1. Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
2. Previous participation in another study with any investigational drug or device within the past 30 days.
3. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult.
4. Known hypersensitivity to paclitaxel or structurally-related compounds.
5. Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
6. Stenosis with corresponding thrombosis treated within 7 days before enrollment.
7. Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
8. Infected grafts/fistulae.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; NMB's PTA Balloon catheter with Paclitaxel drug	Device: NMB Paclitaxel Drug Ejecting Balloon; NMB's PTA Balloon catheter with drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restenosis rate	Binary Stenosis is defined as ≥50% narrowing in luminal diameter basen upon comparison with the adjacent normal vessel. Restenosis Rate - comparison shall be performed both to the patient previous data as well as to restenosis rate data published in the literature for standard PTA balloon catheter procedure	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Easy insertion and removal		intraprocedural
restenosis rate	As defined above in the primary end point	1, 3 and 12 months
Major adverse events rate	All adverse events will be reviewed by the Investigator and evaluated as follows: Nature of the event.; Severity of the event - serious, moderate, mild.; Relation of the adverse event to the device - unrelated, possible, definite	intraprocedural 1, 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: N.M.B. Medical Applications Ltd

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 24, 2012
• Last Update Submitted That Met QC Criteria: July 22, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: NMB AVS HSR