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Study of NMB Drug Ejecting Balloon for Peripheral Arteries

This study is not yet open for participant recruitment.
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:
NCT01646801
First received: July 16, 2012
Last updated: July 22, 2012
Last verified: July 2012
History of Changes

July 16, 2012
July 22, 2012
January 2013
January 2014   (final data collection date for primary outcome measure)
Late Lumen Loss (LLL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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)
Late Lumen Loss (LLL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01646801 on ClinicalTrials.gov Archive Site
  • Restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Restenosis is defined as stenosis of at least 50% of the luminal diameter at 6 months
  • Device Malfunction [ Time Frame: intraprocedural, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: intraprocedural, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Device Malfunction [ Time Frame: intraprocedural, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: intraprocedural, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of NMB Drug Ejecting Balloon for Peripheral Arteries
The Use of NMB Drug Ejecting Balloon for Treatment of Patients With Peripheral Arterial Disease

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Arterial Disease
Device: NMB Balloon Catheter
patients treated by the NMB's Drug Ejecting Balloon
Experimental: Experimental
NMB's Paclitaxel Drug ejecting balloon catheter
Intervention: Device: NMB Balloon Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
January 2015
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Eli Atar, MD 972-3-9376389 elia@clalit.org.il
Israel
 
NCT01646801
NMB PP CLD 2158
Not Provided
N.M.B. Medical Applications Ltd
N.M.B. Medical Applications Ltd
Not Provided
Not Provided
N.M.B. Medical Applications Ltd
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP