Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

Intracranial Aneurysms Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01084681
• Other study ID #: Balt 2010-01
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2010
• Last updated: June 7, 2011
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2011
• Source: Balt International
• Contact: Linda Nicolini, MBA
• Phone: +33 1 39894641
• Email: linda.nicolini[@]balt.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Research Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Switzerland: SwissmedicIsrael: Ethics CommissionTurkey: Ethics Committee
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• Endovascular treatment of intracranial aneurysms
Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
• Endovascular treatment of intracranial aneurysm with coils
Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Würzburg; Abteilung für Neuroradiologie	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Balt International

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No
Secondary	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.	12 months	No