Study of NMB Drug Ejecting Balloon for Peripheral Arteries

Study Overview
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Brief Summary
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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.

Official Title
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The Use of NMB Drug Ejecting Balloon for Treatment of Patients With Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: NMB Balloon Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>NMB's Paclitaxel Drug ejecting balloon catheter | Device: NMB Balloon Catheter<br>* patients treated by the NMB's Drug Ejecting Balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss (LLL) | 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate | Restenosis is defined as stenosis of at least 50% of the luminal diameter at 6 months | 6 months | 
| Device Malfunction |  | intraprocedural, 3, 6 and 12 months | 
| Adverse events |  | intraprocedural, 3, 6 and 12 months |