AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment

Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment

Prospective, multicenter, randomized clinical trial, Follow-up at 1-, 6- and 12 months

This clinical investigation is first of all designed to demonstrate the safety and effectiveness of the MAGIC EXPLORER stent system. The primary objectives of the study are to evaluate the safety and 6-month patency of the bioabsorbable MAGIC EXPLORER stent in patients with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries. Secondary endpoints are the procedural success, patency at all follow-ups, late lumen loss and limb-salvage rate. Peri-procedural complications (within 24 hours) will be evaluated. Furthermore, data of the balloon catheter PLEON EXPLORER will be collected to demonstrate its effectiveness and safety.

Inclusion Criteria:

• Stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
• Length of lesion < 20mm (less than one stent length)
• Reference vessel diameter should be 3.0-3.5 mm
• A maximum of two lesions in one infrapopliteal vessel treated within the study, or in two vessels of two different legs. (PTA treatment of other infrapopliteal lesions in non-study vessels is allowed outside the study).
• Symptomatic critical limb ischemia (Rutherford 4, 5)
• The patient must be ≥ 50 years.
• Life-expectancy of more than 6 months
• The subject or legal guardian has been informed of the nature of the study; agrees to its provisions and has signed informed consent
• The patient must be available for the appropriate follow-up times for the duration of the study
• The patient is capable to follow all study requirements.

Exclusion Criteria:

• Patient refusing treatment
• The reference segment diameter is not suitable for available stent design
• Length of lesion requires more than one stent implantation
• Previously implanted stent(s) or PTA at the same lesion site
• Lesion lies within or adjacent to an aneurysm
• Inflow-limiting arterial lesions left untreated
• The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
• The patient takes Phenprocoumon (Marcumar).
• The patient has a history of prior life-threatening contrast media reaction.
• The patient is currently enrolled in another investigational device or drug trial.
• The patient is currently breast-feeding, pregnant or intends to become pregnant.
• The patient is mentally ill or retarded.
• The patient is liable for military or civilian service.