Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

NCT01646788 | Unknown

• 1 other identifier: NMB AVS HSR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Lesions of Arteriovenous Dialysis Fistulae

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• restenosis rate

  1, 3 and 12 months

• Easy insertion and removal

  intraprocedural

• Major adverse events rate

  intraprocedural 1, 3, 6 and 12 months

Study Arms (1)

Experimental

EXPERIMENTAL

NMB's PTA Balloon catheter with Paclitaxel drug

Device: NMB Paclitaxel Drug Ejecting Balloon

Interventions

NMB Paclitaxel Drug Ejecting Balloon DEVICE

NMB's PTA Balloon catheter with drug

Experimental

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

The Rabin Medical Center, Hasharon Hospital

Petah Tikva, Israel

Location

Central Study Contacts

Eli Atar, MD

CONTACT

972-3-9376389; elia@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 20, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

IL (1)