NCT00572494

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

Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	MAGIC EXPLORER (Biotronik AG)	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.
DEVICE	PLEON EXPLORER (Biotronik AG)	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.

Timeline

• Start date: 2005-07-01
• Completion: 2007-01-01
• First posted: 2007-12-13
• Last updated: 2008-02-08

Locations

12 sites across 4 countries: Austria, Belgium, Germany, Netherlands