Study of NMB Drug Ejecting Balloon for Peripheral Arteries
NCT ID: NCT01646801
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2013-01-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
NMB's Paclitaxel Drug ejecting balloon catheter
NMB Balloon Catheter
patients treated by the NMB's Drug Ejecting Balloon
Interventions
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NMB Balloon Catheter
patients treated by the NMB's Drug Ejecting Balloon
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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N.M.B. Medical Applications Ltd
INDUSTRY
Responsible Party
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Locations
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The Rabin Medical Center, Hasharon Hospital
Petah Tikva, , Israel
Countries
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Central Contacts
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Other Identifiers
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NMB PP CLD 2158
Identifier Type: -
Identifier Source: org_study_id