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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Stenting with AMS

Group Type EXPERIMENTAL

MAGIC EXPLORER (Biotronik AG)

Intervention Type DEVICE

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

PTA alone

Group Type ACTIVE_COMPARATOR

PLEON EXPLORER (Biotronik AG)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No