Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
|ClinicalTrials.gov Identifier: NCT01084681|
Recruitment Status : Unknown
Verified June 2011 by Balt International.
Recruitment status was: Recruiting
First Posted : March 10, 2010
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysms||Device: Endovascular treatment of intracranial aneurysms Device: Endovascular treatment of intracranial aneurysm with coils||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2012|
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).
Device: Endovascular treatment of intracranial aneurysms
Endovascular treatment with the SILK Artery Reconstruction Device for occluding 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.
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
- 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.
- Safety [ Time Frame: 12 months ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084681
|Contact: Linda Nicolini, MBA||+33 1 firstname.lastname@example.org|
|Contact: Alan Cohen, BS||+32 473 email@example.com|
|Universitätsklinikum Würzburg; Abteilung für Neuroradiologie||Recruiting|
|Wuerzburg, Germany, 97080|
|Contact: Linda Nicolini, MBA +33 1 39894641 firstname.lastname@example.org|
|Contact: Alan Cohen, BS +32 473 865091 email@example.com|
|Principal Investigator: László Solymosi, MD|
|Study Chair:||Jacques Moret, MD||Beaujon Hospital - Paris Diderot University (Paris, France)|