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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
The lesion is pre-dilated with the PLEON EXPLORER balloon with a length of 10 mm or 15 mm or 20 mm under angiographic control. After dilation, the stenosed area is treated by one AMS implant. If the implanted stent is not fully apposed to the vessel wall or if initial angiography reveals a residual stenosis, the stent may be post-dilated with the delivery system balloon. If necessary, a high-pressure, non-compliant balloon catheter may be used.
The lesion is dilated with the PLEON EXPLORER balloon with lengths of 10 mm or 15 mm or 20 mm, respectively. In case that the PTA procedure results in a residual stenosis of \>50%, the AMS implant should be used to improve the result. A flow-limiting dissection does not qualify for stenting. Best effort must be made to obtain a satisfactory result (e.g. multiple and prolonged inflations) before a patient in the PTA group can be treated with a stent.
Medizinische Universität Graz
Graz, Austria
A.ö. Landeskrankenhaus Klagenfurt
Klagenfurt, Austria
Allgem. Krankenhaus Vienna
Vienna, Austria
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Imelda Ziekenhuis Bonheiden
Bonheiden, Belgium
AZ St-Blasius
Dendermonde, Belgium
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Humaine Kliniken Bad Saarow
Bad Saarow, Germany
Ev. Krankenhaus Herberge Berlin
Berlin, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
...and 2 more locations
Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)
Time frame: 6 month
Safety: Complications at 1 month post-procedure (major amputations or any cause of death)
Time frame: 1 month
Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area.
Time frame: procedure
Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU)
Time frame: 1 & 6 months
Late lumen loss at 6 months.
Time frame: 6 months
Limb-salvage rate at follow-up visits, defined as lack of major amputation.
Time frame: 1 & 6 months
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