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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: NMB Balloon Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel
    • The Rabin Medical Center, Hasharon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: N.M.B. Medical Applications Ltd

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 24, 2012
• Last Update Submitted That Met QC Criteria: July 22, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: NMB PP CLD 2158