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Home » Clinical Trials » Aneurysm

Clinical Trial Details

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Intracranial Aneurysms

Research Study 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)

Purpose

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 Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Balt International

Duration

31 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

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.

Site Locations (1)

Country State City Zip Facility and Contact
Germany Wuerzburg 97080 Universitätsklinikum Würzburg; Abteilung für Neuroradiologie
Linda Nicolini, MBA
+33 1 39894641
linda.nicolini@balt.fr

László Solymosi, MD
Principal Investigator

Contact

Linda Nicolini, MBA
+33 1 39894641
E-mail:

NCT ID: NCT01084681

Date Last Changed: June 7, 2011

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