NCT01538108

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

February 15, 2012

Last Update Submit

February 22, 2012

Conditions

Obstructive Lesions of Arteriovenous Dialysis Fistulae

Outcome Measures

Primary Outcomes (1)

  • Restenosis Rate

    6 months

Secondary Outcomes (3)

  • Restenosis rate

    1,3 and 12 months

  • Easy insertion and removal

    intraprocedural

  • Major adverse events

    intraprocedural, 1, 3, 6 and 12 months

Study Arms (2)

NMB's PTA Balloon catheter with paclitaxel

EXPERIMENTAL
Device: PTA Balloon catheter with paclitaxel

Standard Angioplasty Balloon

ACTIVE COMPARATOR
Procedure: Plain Balloon angioplasty (PBA)

Interventions

PTA Balloon catheter with paclitaxelDEVICE

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

NMB's PTA Balloon catheter with paclitaxel
Plain Balloon angioplasty (PBA)PROCEDURE

PBA

Standard Angioplasty Balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients 18 years and older
  • Patients with arteriovenous fistula with obstructive lesion
  • Patient who is willing and able to sign a written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

Central Study Contacts

Uri Rimon, MD

CONTACT

972-3-5302530Uri.Rimon@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 23, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations

IL(1)