AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment (AMS-INSIGHT1)

Flanders Medical Research Program

Status and phase

Completed

Phase 2

Conditions

Peripheral Artery Disease

Treatments

Device: PLEON EXPLORER (Biotronik AG)

Device: MAGIC EXPLORER (Biotronik AG)

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00572494

BIOTRONIK Reference 27-1

Details and patient eligibility

About

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.

Enrollment

117 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.