Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

Obstructive Lesions of Arteriovenous Dialysis Fistulae Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01646788
• Other study ID #: NMB AVS HSR
• Status: Not yet recruiting
• Phase: N/A
• First received: July 16, 2012
• Last updated: July 22, 2012
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: July 2012
• Source: N.M.B. Medical Applications Ltd
• Contact: Eli Atar, MD
• Phone: 972-3-9376389
• Email: elia[@]clalit.org.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) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Obstructive Lesions of Arteriovenous Dialysis Fistulae

Intervention

Device:
• NMB Paclitaxel Drug Ejecting Balloon
NMB's PTA Balloon catheter with drug

Locations

Country	Name	City	State
Israel	The Rabin Medical Center, Hasharon Hospital	Petah Tikva

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	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	No
Secondary	restenosis rate	As defined above in the primary end point	1, 3 and 12 months	No
Secondary	Easy insertion and removal		intraprocedural	Yes
Secondary	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	Yes