Study of NMB Drug Ejecting Balloon for Peripheral Arteries

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Device: NMB Balloon Catheter

• Registration Number: NCT01646801
• Lead Sponsor: N.M.B. Medical Applications Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Last Update Submitted: 2012-07-22
• Last Update Posted: 2012-07-24
• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	NMB Balloon Catheter	NMB's Paclitaxel Drug ejecting balloon catheter

Primary Outcome Measures

Name	Time	Method
Late Lumen Loss (LLL)	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)

Secondary Outcome Measures

Name	Time	Method
Device Malfunction	intraprocedural, 3, 6 and 12 months
Adverse events	intraprocedural, 3, 6 and 12 months
Restenosis rate	6 months	Restenosis is defined as stenosis of at least 50% of the luminal diameter at 6 months

Trial Locations

Locations (1)

The Rabin Medical Center, Hasharon Hospital; 🇮🇱 Petah Tikva, Israel