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

Phase 2

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: MAGIC EXPLORER (Biotronik AG); Device: PLEON EXPLORER (Biotronik AG)

• Registration Number: NCT00572494
• Lead Sponsor: Flanders Medical Research Program

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study Completion: 2007-01
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-07
• Last Update Posted: 2008-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MAGIC EXPLORER (Biotronik AG)	Stenting with AMS
2	PLEON EXPLORER (Biotronik AG)	PTA alone

Primary Outcome Measures

Name	Time	Method
Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)	6 month
Safety: Complications at 1 month post-procedure (major amputations or any cause of death)	1 month

Secondary Outcome Measures

Name	Time	Method
Limb-salvage rate at follow-up visits, defined as lack of major amputation.	1 & 6 months
Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area.	procedure
Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU)	1 & 6 months
Late lumen loss at 6 months.	6 months

Trial Locations

Locations (12)

AZ St-Blasius; 🇧🇪 Dendermonde, Belgium

Sint-Elisabeth Ziekenhuis Tilburg; 🇳🇱 Tilburg, Netherlands

Allgem. Krankenhaus Vienna; 🇦🇹 Vienna, Austria

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

Medizinische Universität Graz; 🇦🇹 Graz, Austria

A.ö. Landeskrankenhaus Klagenfurt; 🇦🇹 Klagenfurt, Austria

Imelda Ziekenhuis Bonheiden; 🇧🇪 Bonheiden, Belgium

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Ev. Krankenhaus Herberge Berlin; 🇩🇪 Berlin, Germany

Humaine Kliniken Bad Saarow; 🇩🇪 Bad Saarow, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Mainz; 🇩🇪 Mainz, Germany