Study of NMB Drug Ejecting Balloon for Peripheral Arteries

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by N.M.B. Medical Applications Ltd
Sponsor:
Information provided by (Responsible Party):
N.M.B. Medical Applications Ltd
ClinicalTrials.gov Identifier:
NCT01646801
First received: July 16, 2012
Last updated: July 22, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Device: NMB Balloon Catheter

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of NMB Drug Ejecting Balloon for Treatment of Patients With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by N.M.B. Medical Applications Ltd:

Primary Outcome Measures:
  • Late Lumen Loss (LLL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Restenosis is defined as stenosis of at least 50% of the luminal diameter at 6 months

  • Device Malfunction [ Time Frame: intraprocedural, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: intraprocedural, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
NMB's Paclitaxel Drug ejecting balloon catheter
Device: NMB Balloon Catheter
patients treated by the NMB's Drug Ejecting Balloon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646801

Contacts
Contact: Eli Atar, MD 972-3-9376389 elia@clalit.org.il

Locations
Israel
The Rabin Medical Center, Hasharon Hospital Not yet recruiting
Petah Tikva, Israel
Sponsors and Collaborators
N.M.B. Medical Applications Ltd
  More Information

No publications provided

Responsible Party: N.M.B. Medical Applications Ltd
ClinicalTrials.gov Identifier: NCT01646801     History of Changes
Other Study ID Numbers: NMB PP CLD 2158
Study First Received: July 16, 2012
Last Updated: July 22, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014