Study of NMB Drug Ejecting Balloon for Peripheral Arteries

This is an interventional treatment trial for Peripheral Arterial Disease Read More

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.