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

Peripheral Artery Disease Clinical Trial

— AMS-INSIGHT1  

Official title:

Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572494
• Other study ID #: BIOTRONIK Reference 27-1
• Secondary ID: Not available
• Status: Completed
• Phase: Phase 2
• First received: December 12, 2007
• Last updated: February 7, 2008
• Start date: July 2005
• Est. completion date: January 2007

Study information

• Verified date: February 2008
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardGermany: Ethics CommissionNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Flanders Medical Research Program	Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)		6 month	No
Primary	Safety: Complications at 1 month post-procedure (major amputations or any cause of death)		1 month	Yes
Secondary	Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area.		procedure	No
Secondary	Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU)		1 & 6 months	No
Secondary	Late lumen loss at 6 months.		6 months	No
Secondary	Limb-salvage rate at follow-up visits, defined as lack of major amputation.		1 & 6 months	No