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Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by N.M.B. Medical Applications Ltd.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01646788
First Posted: July 20, 2012
Last Update Posted: July 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
N.M.B. Medical Applications Ltd
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

    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 ]
    As defined above in the primary end point

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

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: N.M.B. Medical Applications Ltd
ClinicalTrials.gov Identifier: NCT01646788     History of Changes
Other Study ID Numbers: NMB AVS HSR
First Submitted: July 16, 2012
First Posted: July 20, 2012
Last Update Posted: July 24, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action