Study of NMB Drug Ejecting Balloon for Peripheral Arteries

NCT01646801 | Unknown

• 1 other identifier: NMB PP CLD 2158
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Restenosis rate

  6 months

• Device Malfunction

  intraprocedural, 3, 6 and 12 months

• Adverse events

  intraprocedural, 3, 6 and 12 months

Study Arms (1)

Experimental

EXPERIMENTAL

NMB's Paclitaxel Drug ejecting balloon catheter

Device: NMB Balloon Catheter

Interventions

NMB Balloon Catheter DEVICE

patients treated by the NMB's Drug Ejecting Balloon

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Rabin Medical Center, Hasharon Hospital

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Eli Atar, MD

CONTACT

972-3-9376389; elia@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 20, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

IL (1)