Clinical trial NCT00572494: AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
Official title: Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Artery Disease
Keywords: Tibial arteries
Absorbable implants
Stents
Limb salvage
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
Collaborators: name: Biotronik SE & Co. KG
First posted: 2007-12-13
Enrollment: 117
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)
timeFrame: 6 month
measure: Safety: Complications at 1 month post-procedure (major amputations or any cause of death)
timeFrame: 1 month
Secondary outcomes:
measure: Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area.
timeFrame: procedure
measure: Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU)
timeFrame: 1 & 6 months
measure: Late lumen loss at 6 months.
timeFrame: 6 months
measure: Limb-salvage rate at follow-up visits, defined as lack of major amputation.
timeFrame: 1 & 6 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Klagenfurt
country: Austria
facility: A.ö. Landeskrankenhaus Klagenfurt
city: Vienna
country: Austria
facility: Allgem. Krankenhaus Vienna
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis Bonheiden
city: Dendermonde
country: Belgium
facility: AZ St-Blasius
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Saarow
country: Germany
facility: Humaine Kliniken Bad Saarow
city: Berlin
country: Germany
facility: Ev. Krankenhaus Herberge Berlin
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: Tilburg
country: Netherlands
facility: Sint-Elisabeth Ziekenhuis Tilburg
Study officials:
affiliation: AZ Sint-Blasius, Dendermonde, Belgium
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biotronik SE & Co. KG
name: Evelyn Diessel, PhD
role: STUDY_DIRECTOR
References: