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Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by N.M.B. Medical Applications Ltd
Sponsor:
Information provided by (Responsible Party):
N.M.B. Medical Applications Ltd
ClinicalTrials.gov Identifier:
NCT01646788
First received: July 16, 2012
Last updated: July 22, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Obstructive Lesions of Arteriovenous Dialysis Fistulae
Device: NMB Paclitaxel Drug Ejecting Balloon

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

Resource links provided by NLM:


Further study details as provided by N.M.B. Medical Applications Ltd:

Primary Outcome Measures:
  • Restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • restenosis rate [ Time Frame: 1, 3 and 12 months ] [ Designated as safety issue: No ]
    As defined above in the primary end point

  • Easy insertion and removal [ Time Frame: intraprocedural ] [ Designated as safety issue: Yes ]
  • Major adverse events rate [ Time Frame: intraprocedural 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
NMB's PTA Balloon catheter with Paclitaxel drug
Device: NMB Paclitaxel Drug Ejecting Balloon
NMB's PTA Balloon catheter with drug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646788

Contacts
Contact: Eli Atar, MD 972-3-9376389 elia@clalit.org.il

Locations
Israel
The Rabin Medical Center, Hasharon Hospital Not yet recruiting
Petah Tikva, Israel
Sponsors and Collaborators
N.M.B. Medical Applications Ltd
  More Information

No publications provided

Responsible Party: N.M.B. Medical Applications Ltd
ClinicalTrials.gov Identifier: NCT01646788     History of Changes
Other Study ID Numbers: NMB AVS HSR
Study First Received: July 16, 2012
Last Updated: July 22, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014