Study of NMB Drug Ejecting Balloon for Peripheral Arteries

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01646801
• Other study ID #: NMB PP CLD 2158
• Status: Not yet recruiting
• Phase: N/A
• First received: July 16, 2012
• Last updated: July 22, 2012
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: July 2012
• Source: N.M.B. Medical Applications Ltd
• Contact: Eli Atar, MD
• Phone: 972-3-9376389
• Email: elia[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• NMB Balloon Catheter
patients treated by the NMB's Drug Ejecting Balloon

Locations

Country	Name	City	State
Israel	The Rabin Medical Center, Hasharon Hospital	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
N.M.B. Medical Applications Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Restenosis rate	Restenosis is defined as stenosis of at least 50% of the luminal diameter at 6 months	6 months	No
Secondary	Device Malfunction		intraprocedural, 3, 6 and 12 months	Yes
Secondary	Adverse events		intraprocedural, 3, 6 and 12 months	Yes