Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

Not Applicable

• Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae
• Interventions: Device: NMB Paclitaxel Drug Ejecting Balloon

• Registration Number: NCT01646788
• Lead Sponsor: N.M.B. Medical Applications Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Last Update Submitted: 2012-07-22
• Last Update Posted: 2012-07-24
• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	NMB Paclitaxel Drug Ejecting Balloon	NMB's PTA Balloon catheter with Paclitaxel drug

Primary Outcome Measures

Name	Time	Method
Restenosis rate	6 months	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

Secondary Outcome Measures

Name	Time	Method
restenosis rate	1, 3 and 12 months	As defined above in the primary end point
Easy insertion and removal	intraprocedural
Major adverse events rate	intraprocedural 1, 3, 6 and 12 months	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

Trial Locations

Locations (1)

The Rabin Medical Center, Hasharon Hospital; 🇮🇱 Petah Tikva, Israel