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Study of NMB Drug Ejecting Balloon for Peripheral Arteries

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:
NCT01646801
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
July 16, 2012
July 20, 2012
July 24, 2012
January 2013
January 2014   (Final data collection date for primary outcome measure)
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)
Late Lumen Loss (LLL) [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01646801 on ClinicalTrials.gov Archive Site
  • Restenosis rate [ Time Frame: 6 months ]
    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 ]
  • Adverse events [ Time Frame: intraprocedural, 3, 6 and 12 months ]
  • Restenosis rate [ Time Frame: 6 months ]
  • Device Malfunction [ Time Frame: intraprocedural, 3, 6 and 12 months ]
  • Adverse events [ Time Frame: intraprocedural, 3, 6 and 12 months ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01646801
NMB PP CLD 2158
Not Provided
Not Provided
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