Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Balt International.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Balt International
ClinicalTrials.gov Identifier:
NCT01084681
First received: March 8, 2010
Last updated: June 7, 2011
Last verified: June 2011

March 8, 2010
June 7, 2011
March 2010
October 2012   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01084681 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Safety will be evaluated as follows:

  1. Peri-procedural ischemic and hemorrhagic adverse events
  2. Peri-procedural technical complications
  3. Death from any cause
  4. Neurological deterioration
  5. Cranial nerve deficit
  6. 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.

Same as current
Not Provided
Not Provided
 
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Intracranial Aneurysms
  • Device: Endovascular treatment of intracranial aneurysms
    Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
    Other Name: Endovascular treatment of intracranial aneurysms
  • Device: Endovascular treatment of intracranial aneurysm with coils
    Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.
    Other Name: Endovascular treatment of intracranial aneurysms
  • Active Comparator: SILK Artery Reconstruction Device
    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).
    Intervention: Device: Endovascular treatment of intracranial aneurysms
  • Active Comparator: Coils
    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.
    Intervention: Device: Endovascular treatment of intracranial aneurysm with coils
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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)
  • 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.
Both
18 Years and older
No
Contact: Linda Nicolini, MBA +33 1 39894641 linda.nicolini@balt.fr
Contact: Alan Cohen, BS +32 473 865091 alanscohen@skynet.be
Germany
 
NCT01084681
Balt 2010-01
No
Linda Nicolini / Director of Market Development, Balt International
Balt International
Not Provided
Study Chair: Jacques Moret, MD Beaujon Hospital - Paris Diderot University (Paris, France)
Balt International
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP