Peripheral Artery DiseasePhase 2AMS-INSIGHT1NCT00572494
AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
A Phase 2 study testing MAGIC EXPLORER (Biotronik AG) and PLEON EXPLORER (Biotronik AG) in people with Peripheral Artery Disease, run by Flanders Medical Research Program at 12 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- MAGIC EXPLORER (Biotronik AG) and PLEON EXPLORER (Biotronik AG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Jul 2005to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany5 sites
Herzzentrum Bad Krozingen
Bad Krozingen
Humaine Kliniken Bad Saarow
Bad Saarow
Ev. Krankenhaus Herberge Berlin
Berlin
Universitätsklinikum Leipzig
Leipzig
Universitätsklinikum Mainz
Mainz
Austria3 sites
Medizinische Universität Graz
Graz
A.ö. Landeskrankenhaus Klagenfurt
Klagenfurt
Allgem. Krankenhaus Vienna
Vienna
Belgium3 sites
Universitair Ziekenhuis Antwerpen
Antwerp
Imelda Ziekenhuis Bonheiden
Bonheiden
AZ St-Blasius
Dendermonde, 9200
About this study
Official title: Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
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.
- Conditions
- Peripheral Artery Disease
- Being tested
- MAGIC EXPLORER (Biotronik AG), PLEON EXPLORER (Biotronik AG)
- Keywords
- Tibial arteries, Absorbable implants, Stents, Limb salvage
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGIC EXPLORER (Biotronik AG)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.
PLEON EXPLORER (Biotronik AG)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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Stenting with AMS Receives: Device: MAGIC EXPLORER (Biotronik AG) |
| 2 | Active comparator | PTA alone Receives: Device: PLEON EXPLORER (Biotronik AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)
Measured: 6 month
Safety: Complications at 1 month post-procedure (major amputations or any cause of death)
Measured: 1 month
Secondary outcomes (4)
Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area.
Measured: procedure
Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU)
Measured: 1 & 6 months
Late lumen loss at 6 months.
Measured: 6 months
Limb-salvage rate at follow-up visits, defined as lack of major amputation.
Measured: 1 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJul 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Collaborators
- Biotronik SE & Co. KG
- Investigators
- Marc Bosiers, MD, Principal investigator, AZ Sint-Blasius, Dendermonde, BelgiumEvelyn Diessel, PhD, Study director, Biotronik SE & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572494
- Sponsor's protocol ID
- BIOTRONIK Reference 27-1
- Acronym
- AMS-INSIGHT1
- Status last verified
- Feb 2008
- First submitted
- 12 Dec 2007
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
- ClinicalTrials.gov ID
- NCT00572494
- Acronym / sponsor ID
- AMS-INSIGHT1 / BIOTRONIK Reference 27-1
- Conditions
- Peripheral Artery Disease
- Keywords
- Tibial arteries, Absorbable implants, Stents, Limb salvage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Collaborators
- Biotronik SE & Co. KG
- Study start
- Jul 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: MAGIC EXPLORER (Biotronik AG)Stenting with AMS |
| 2 | Active comparator | Device: PLEON EXPLORER (Biotronik AG)PTA alone |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | 1 |
| 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. | Device | 2 |
Primary outcome
Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)
Time frame: 6 month
Safety: Complications at 1 month post-procedure (major amputations or any cause of death)
Time frame: 1 month
4 secondary outcomes
Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area.
Time frame: procedure
Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU)
Time frame: 1 & 6 months
Late lumen loss at 6 months.
Time frame: 6 months
Limb-salvage rate at follow-up visits, defined as lack of major amputation.
Time frame: 1 & 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Bosiers, MD principal investigator
AZ Sint-Blasius, Dendermonde, Belgium
Evelyn Diessel, PhD study director
Biotronik SE & Co. KG
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAGIC EXPLORER (Biotronik AG) and PLEON EXPLORER (Biotronik AG) in people with Peripheral Artery Disease, run by Flanders Medical Research Program at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Austria, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%) (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2008.