Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

N.M.B. Medical Applications

Status: Unknown

Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae

Treatments: Device: NMB Paclitaxel Drug Ejecting Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT01646788

NMB AVS HSR

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Experimental

Experimental group

Description:

NMB's PTA Balloon catheter with Paclitaxel drug

Treatment:

Device: NMB Paclitaxel Drug Ejecting Balloon