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Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

NCT01084681 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2011-06-08

No results posted yet for this study

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 available intracranial coils in the endovascular treatment (occlusion) of intracranial aneurysms.

Conditions

  • Intracranial Aneurysms

Interventions

DEVICE

Endovascular treatment of intracranial aneurysms

Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.

DEVICE

Endovascular treatment of intracranial aneurysm with coils

Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.

Sponsors & Collaborators

  • Balt International

    lead INDUSTRY

Principal Investigators

  • Jacques Moret, MD · Beaujon Hospital - Paris Diderot University (Paris, France)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084681 on ClinicalTrials.gov