Study of NMB (Company's Name) Drug Ejecting Balloon for Arteriovenous Fistulae

Obstructive Lesions of Arteriovenous Dialysis Fistulae Clinical Trial

Official title:

The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01538108
• Other study ID #: NMB AVS P
• Status: Not yet recruiting
• Phase: N/A
• First received: February 15, 2012
• Last updated: February 22, 2012
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: February 2012
• Source: N.M.B. Medical Applications Ltd
• Contact: Uri Rimon, MD
• Phone: 972-3-5302530
• Email: Uri.Rimon[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients 18 years and older

• Patients with arteriovenous fistula with obstructive lesion

• Patient who is willing and able to sign a written informed consent

Exclusion Criteria:

• age < 18

• female with child bearing potential

• Previous participation in another study with any investigational drug or device within the past 30 days

• Life expectancy of less than 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Obstructive Lesions of Arteriovenous Dialysis Fistulae

Intervention

Device:
• PTA Balloon catheter with paclitaxel
patients treated by the NMB's PTA Balloon catheter with paclitaxel

Procedure:
• Plain Balloon angioplasty (PBA)
PBA

Locations

Country	Name	City	State
Israel	The Chaim Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
N.M.B. Medical Applications Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restenosis Rate		6 months	No
Secondary	Restenosis rate		1,3 and 12 months	No
Secondary	Easy insertion and removal		intraprocedural	Yes
Secondary	Major adverse events		intraprocedural, 1, 3, 6 and 12 months	Yes