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AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment (AMS-INSIGHT1)

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MAGIC EXPLORER (Biotronik AG)
PLEON EXPLORER (Biotronik AG)
Sponsored by
Flanders Medical Research Program
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Tibial arteries, Absorbable implants, Stents, Limb salvage

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Stenting with AMS

PTA alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2007
Last Updated
February 7, 2008
Sponsor
Flanders Medical Research Program
Collaborators
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT00572494
Brief Title
AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
Acronym
AMS-INSIGHT1
Official Title
Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Flanders Medical Research Program
Collaborators
Biotronik SE & Co. KG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Tibial arteries, Absorbable implants, Stents, Limb salvage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Stenting with AMS
Arm Title
2
Arm Type
Active Comparator
Arm Description
PTA alone
Intervention Type
Device
Intervention Name(s)
MAGIC EXPLORER (Biotronik AG)
Intervention Description
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
Intervention Name(s)
PLEON EXPLORER (Biotronik AG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)
Time Frame
6 month
Title
Safety: Complications at 1 month post-procedure (major amputations or any cause of death)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area.
Time Frame
procedure
Title
Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU)
Time Frame
1 & 6 months
Title
Late lumen loss at 6 months.
Time Frame
6 months
Title
Limb-salvage rate at follow-up visits, defined as lack of major amputation.
Time Frame
1 & 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bosiers, MD
Organizational Affiliation
AZ Sint-Blasius, Dendermonde, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evelyn Diessel, PhD
Organizational Affiliation
Biotronik SE & Co. KG
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Universität Graz
City
Graz
Country
Austria
Facility Name
A.ö. Landeskrankenhaus Klagenfurt
City
Klagenfurt
Country
Austria
Facility Name
Allgem. Krankenhaus Vienna
City
Vienna
Country
Austria
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
Imelda Ziekenhuis Bonheiden
City
Bonheiden
Country
Belgium
Facility Name
AZ St-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Humaine Kliniken Bad Saarow
City
Bad Saarow
Country
Germany
Facility Name
Ev. Krankenhaus Herberge Berlin
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum Mainz
City
Mainz
Country
Germany
Facility Name
Sint-Elisabeth Ziekenhuis Tilburg
City
Tilburg
Country
Netherlands

12. IPD Sharing Statement

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

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