Study of NMB Drug Ejecting Balloon for Peripheral Arteries

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. Identifier: NCT01646801
Recruitment Status : Unknown
Verified July 2012 by N.M.B. Medical Applications Ltd.
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2012
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
N.M.B. Medical Applications Ltd

Brief Summary:
The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral arterial disease.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: NMB Balloon Catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of NMB Drug Ejecting Balloon for Treatment of Patients With Peripheral Arterial Disease
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental
NMB's Paclitaxel Drug ejecting balloon catheter
Device: NMB Balloon Catheter
patients treated by the NMB's Drug Ejecting Balloon

Primary Outcome Measures :
  1. Late Lumen Loss (LLL) [ Time Frame: 6 months ]
    Late Lumen Loss (LLL) defined as the difference between the minimal luminal diameter after the procedure and at 6 months, as evaluated by Quantitative Angiography (mm units will be used)

Secondary Outcome Measures :
  1. Restenosis rate [ Time Frame: 6 months ]
    Restenosis is defined as stenosis of at least 50% of the luminal diameter at 6 months

  2. Device Malfunction [ Time Frame: intraprocedural, 3, 6 and 12 months ]
  3. Adverse events [ Time Frame: intraprocedural, 3, 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients 18 years old or older
  • Patient with lifestyle limiting claudication or rest pain (Rutherford- Becker scale 2, 3 or 4).
  • Patient with de novo lesion or restenotic lesion ≥70% in the iliac, femoral, popliteal or tibial artery.
  • The target lesion can be successfully crossed with a guide wire and dilated.
  • The target lesion is in a native artery of 2.5-10mm in diameter and less than 80 mm in length.
  • Patient is willing to and able to sign a written informed consent and to comply with procedures (e.g., adherence to follow-up visits, including 6 months CT-angiography/MRA follow-up).

Exclusion Criteria:

  • Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
  • Previous participation in another study with any investigational drug or device within the past 30 days.
  • The patient is currently enrolled in another investigational device or drug trial.
  • Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
  • Stenosis with corresponding thrombosis treated within 7 days before enrollment.
  • Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
  • Patient that has co-morbid illness that may result in life expectancy of less than 12 months.
  • History of haemorrhagic stroke or gastro-intestinal bleeding within 6 months.
  • Patient with major surgery during the 30 days preceding the interventional procedure.

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 identifier (NCT number): NCT01646801

Contact: Eli Atar, MD 972-3-9376389

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

Responsible Party: N.M.B. Medical Applications Ltd Identifier: NCT01646801     History of Changes
Other Study ID Numbers: NMB PP CLD 2158
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases