Study of NMB Drug Ejecting Balloon for Peripheral Arteries

N.M.B. Medical Applications

Status

Unknown

Conditions

Peripheral Arterial Disease

Treatments

Device: NMB Balloon Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT01646801

NMB PP CLD 2158

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.