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

Sponsors and Collaborators:	Flanders Medical Research Program Biotronik GmbH & Co. KG
Information provided by:	Flanders Medical Research Program
ClinicalTrials.gov Identifier:	NCT00572494

Purpose

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.

Condition	Intervention	Phase
Peripheral Artery Disease	Device: MAGIC EXPLORER (Biotronik AG) Device: PLEON EXPLORER (Biotronik AG)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment

Resource links provided by NLM:

Drug Information available for: Sulfasalazine

U.S. FDA Resources

Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:

Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Safety: Complications at 1 month post-procedure (major amputations or any cause of death) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area. [ Time Frame: procedure ] [ Designated as safety issue: No ]
Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU) [ Time Frame: 1 & 6 months ] [ Designated as safety issue: No ]
Late lumen loss at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Limb-salvage rate at follow-up visits, defined as lack of major amputation. [ Time Frame: 1 & 6 months ] [ Designated as safety issue: No ]

Enrollment:	117
Study Start Date:	July 2005
Study Completion Date:	January 2007

Arms	Assigned Interventions
1: Experimental Stenting with AMS	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.
2: Active Comparator PTA alone	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.

Arms

Assigned Interventions

1: Experimental

Stenting with AMS

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.

2: Active Comparator

PTA alone

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572494

Locations

Austria
Medizinische Universität Graz
Graz, Austria
Allgem. Krankenhaus Vienna
Vienna, Austria
A.ö. Landeskrankenhaus Klagenfurt
Klagenfurt, Austria
Belgium
AZ St-Blasius
Dendermonde, Belgium, 9200
Imelda Ziekenhuis Bonheiden
Bonheiden, Belgium
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium
Germany
Universitätsklinikum Mainz
Mainz, Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Humaine Kliniken Bad Saarow
Bad Saarow, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Ev. Krankenhaus Herberge Berlin
Berlin, Germany
Netherlands
Sint-Elisabeth Ziekenhuis Tilburg
Tilburg, Netherlands

Sponsors and Collaborators

Flanders Medical Research Program

Biotronik GmbH & Co. KG

Investigators

Principal Investigator:	Marc Bosiers, MD	AZ Sint-Blasius, Dendermonde, Belgium
Study Director:	Evelyn Diessel, PhD	Biotronik GmbH & Co. KG

More Information

No publications provided

Responsible Party:	AZ Sint-Blasius hospital, Dendermonde, Belgium ( Marc Bosiers, MD )
Study ID Numbers:	BIOTRONIK Reference 27-1, Not available
Study First Received:	December 12, 2007
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00572494 History of Changes
Health Authority:	Austria: Ethikkommission; Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Germany: Ethics Commission; Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Flanders Medical Research Program:

Tibial arteries
Absorbable implants
Stents
Limb salvage

Study placed in the following topic categories:

Sulfasalazine
Ischemia

ClinicalTrials.gov processed this record on July 02, 2009