Intracranial AneurysmsNCT01084681
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
A study testing Endovascular treatment of intracranial aneurysms and Endovascular treatment of intracranial aneurysm with coils in people with Intracranial Aneurysms, run by Balt International at 1 site in Germany.
Trial summary
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents. This post-market clinical investigation compares the efficacy of using the CE-marked, commercially available SILK Artery Reconstruction Device against commercially… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- Endovascular treatment of intracranial aneurysms and Endovascular treatment of intracranial aneurysm with coils
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Oct 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one documented untreated, unruptured intracranial aneurysm
- The intracranial aneurysm is non-thrombosed and non-hemorrhagic
- Saccular Carotid Siphon: with a sac diameter of ≥7mm to ≤15mm
- Lateral vertebral aneurysms of V4, and side-wall basilar trunk aneurysms
- Target aneurysm morphology permits the use of intracranial devices, as determined by the treating physician
- Subject greater than or equal to 18 years old
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- Life expectancy greater than or equal to 12 months
- Subject (or subject's legally authorized representative) has provided written informed consent
- Subject is willing and able to comply with protocol follow-up requirements
Who cannot join
- Subject is under guardianship
- Significant atherosclerotic disease, stenosis, tortuosity or other condition preventing microcatheter access to the target aneurysm(s)
- Vessel branch arising from the aneurysm sac
- Fusiform aneurysm
- Ruptured aneurysm
- Bifurcation aneurysms (MCA, ACoA)
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- Recurrent aneurysm
- Presence of an intracranial stent on the side that is to be treated
- High risk surgical subjects with significant pre-existing co-morbid condition(s), not treated or well controlled with standard therapy
- Bleeding disorder which would preclude percutaneous intervention and/or anti-thrombotic therapy; resistance to anti-platelet treatment
- Intracranial intervention performed within 30 days prior to the procedure or elective intracranial intervention planned within 12 months following the procedure
- Major surgical procedure (e.g., coronary artery bypass graft, valve replacement, abdominal aortic aneurysm repair, bowel resection) performed within 30 days preceding or planned within 12 months following the procedure.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Würzburg; Abteilung für Neuroradiologie
Würzburg, 97080
Linda Nicolini, MBA, +33 1 39894641, linda.nicolini@balt.fr
Alan Cohen, BS, +32 473 865091, alanscohen@skynet.be
About this study
Official title: Multicenter Randomized Trial on Selective Endovascular Aneurysm Occlusion With Coils Versus Parent Vessel Reconstruction Using the SILK Flow Diverter (MARCO POLO Post-Market Clinical Investigation)
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents. This post-market clinical investigation compares the efficacy of using the CE-marked, commercially available SILK Artery Reconstruction Device against commercially available intracranial coils in the endovascular treatment (occlusion) of intracranial aneurysms.
Read the detailed description
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents. The flow diverter stent concept is based upon the hemodynamic exclusion of the aneurysm sac, without coils being eventually placed within the sac. The primary objective of this post-market clinical investigation is to demonstrate that when using the CE-marked, commercially available SILK Artery Reconstruction Device in the indication for which it is approved, notably for the treatment (occlusion) of intracranial aneurysms, the anatomical results are superior compared to standard treatment with commercially available intracranial coils (used with eventual balloon remodeling and/or stents when necessary). It is a prospective, randomized, unblinded, multi-center post-market clinical investigation. The patient population comprises a maximum of 160 subjects with at least one documented untreated, unruptured intracranial aneurysm suitable for occlusion with an intracranial device. Subject enrollment will require a maximum of 18 months. Enrolled subjects will be followed for 12 months after treatment.
- Conditions
- Intracranial Aneurysms
- Being tested
- Endovascular treatment of intracranial aneurysms, Endovascular treatment of intracranial aneurysm with coils
- Keywords
- SILK flow diverter, intracranial stents, intracranial aneurysms
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment of intracranial aneurysmsDevice
Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
Endovascular treatment of intracranial aneurysm with coilsDevice
Also called Endovascular treatment of intracranial aneurysms
Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.
| Study group | Role | What they receive |
|---|---|---|
| SILK Artery Reconstruction Device | Active comparator | One arm will receive only the commercially available SILK Artery Reconstruction Device [flow diverter] (no intracranial coils are to be used in association with the SILK device). Receives: Device: Endovascular treatment of intracranial aneurysms |
| Coils | Active comparator | The other arm will be treated with commercially available intracranial coils: the coils can be used with eventual balloon remodeling and/or stents when necessary. Receives: Device: Endovascular treatment of intracranial aneurysm with coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
The primary objective is to demonstrate that when using the SILK Artery Reconstruction Device in the indication for which it is approved, notably for the treatment (occlusion) of intracranial aneurysms, the anatomical results are superior compared to standard treatment with commercially available intracranial coils. Therefore, angiographic assessment will measure efficacy by determining the percentage of subjects in each of the two arms experiencing complete occlusion of the aneurysm at 12 months post-procedure.
Measured: 12 months
Secondary outcomes (1)
Safety
Safety will be evaluated as follows:
- Peri-procedural ischemic and hemorrhagic adverse events
- Peri-procedural technical complications
- Death from any cause
- Neurological deterioration
- Cranial nerve deficit
- General adverse events
In addition, Subject Quality of Life (QOL) will be measured at baseline and at 12 months post-procedure using the EuroQol questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balt International
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacques Moret, MD, Study chair, Beaujon Hospital - Paris Diderot University (Paris, France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084681
- Sponsor's protocol ID
- Balt 2010-01
- Status last verified
- Jun 2011
- First submitted
- 8 Mar 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Trial on Selective Endovascular Aneurysm Occlusion With Coils Versus Parent Vessel Reconstruction Using the SILK Flow Diverter (MARCO POLO Post-Market Clinical Investigation)
- ClinicalTrials.gov ID
- NCT01084681
- Acronym / sponsor ID
- Balt 2010-01
- Conditions
- Intracranial Aneurysms
- Keywords
- SILK flow diverter, intracranial stents, intracranial aneurysms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Balt InternationalIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 10 Mar 2010 (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.
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents. This post-market clinical investigation compares the efficacy of using the CE-marked, commercially available SILK Artery Reconstruction Device against commercially available intracranial coils in the endovascular treatment (occlusion) of intracranial aneurysms.
Detailed description
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents. The flow diverter stent concept is based upon the hemodynamic exclusion of the aneurysm sac, without coils being eventually placed within the sac. The primary objective of this post-market clinical investigation is to demonstrate that when using the CE-marked, commercially available SILK Artery Reconstruction Device in the indication for which it is approved, notably for the treatment (occlusion) of intracranial aneurysms, the anatomical results are superior compared to standard treatment with commercially available intracranial coils (used with eventual balloon remodeling and/or stents when necessary). It is a prospective, randomized, unblinded, multi-center post-market clinical investigation. The patient population comprises a maximum of 160 subjects with at least one documented untreated, unruptured intracranial aneurysm suitable for occlusion with an intracranial device. Subject enrollment will require a maximum of 18 months. Enrolled subjects will be followed for 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SILK Artery Reconstruction Device | Active comparator | Device: Endovascular treatment of intracranial aneurysmsOne arm will receive only the commercially available SILK Artery Reconstruction Device [flow diverter] (no intracranial coils are to be used in association with the SILK device). |
| Coils | Active comparator | Device: Endovascular treatment of intracranial aneurysm with coilsThe other arm will be treated with commercially available intracranial coils: the coils can be used with eventual balloon remodeling and/or stents when necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least one documented untreated, unruptured intracranial aneurysm
- The intracranial aneurysm is non-thrombosed and non-hemorrhagic
- Saccular Carotid Siphon: with a sac diameter of ≥7mm to ≤15mm
- Lateral vertebral aneurysms of V4, and side-wall basilar trunk aneurysms
- Target aneurysm morphology permits the use of intracranial devices, as determined by the treating physician
Key exclusion criteria (12 listed)
- Subject is under guardianship
- Significant atherosclerotic disease, stenosis, tortuosity or other condition preventing microcatheter access to the target aneurysm(s)
- Vessel branch arising from the aneurysm sac
- Fusiform aneurysm
- Ruptured 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 |
|---|---|---|
| Endovascular treatment of intracranial aneurysmsEndovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms. | Device | SILK Artery Reconstruction Device |
| Endovascular treatment of intracranial aneurysm with coilsAlso: Endovascular treatment of intracranial aneurysmsEndovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms. | Device | Coils |
Primary outcome
Efficacy
Time frame: 12 months
The primary objective is to demonstrate that when using the SILK Artery Reconstruction Device in the indication for which it is approved, notably for the treatment (occlusion) of intracranial aneurysms, the anatomical results are superior compared to standard treatment with commercially available intracranial coils. Therefore, angiographic assessment will measure efficacy by determining the percentage of subjects in each of the two arms experiencing complete occlusion of the aneurysm at 12 months post-procedure.
1 secondary outcome
Safety
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
Jacques Moret, MD study chair
Beaujon Hospital - Paris Diderot University (Paris, France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment of intracranial aneurysms and Endovascular treatment of intracranial aneurysm with coils in people with Intracranial Aneurysms, run by Balt International at 1 site in Germany.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Nicolini, MBA (+33 1 39894641, linda.nicolini@balt.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 12 months). 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 Jun 2011.