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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01646801
Other study ID # NMB PP CLD 2158
Secondary ID
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


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
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