Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques - Full Text View

Sponsor:	Balt International
Information provided by:	Balt International
ClinicalTrials.gov Identifier:	NCT01084681

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.

Condition	Intervention
Intracranial Aneurysms	Device: Endovascular treatment of intracranial aneurysms Device: Endovascular treatment of intracranial aneurysm with coils

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Brain Aneurysm

U.S. FDA Resources

Further study details as provided by Balt International:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	160
Study Start Date:	March 2010
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SILK Artery Reconstruction Device: Active Comparator 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.
Coils: Active Comparator 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.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084681

Contacts

Contact: Linda Nicolini, MBA	+33 1 39894641	linda.nicolini@balt.fr
Contact: Alan Cohen, BS	+32 473 865091	alanscohen@skynet.be

Locations

Germany
Universitätsklinikum Würzburg; Abteilung für Neuroradiologie	Recruiting
Wuerzburg, Germany, 97080
Contact: Linda Nicolini, MBA +33 1 39894641 linda.nicolini@balt.fr
Contact: Alan Cohen, BS +32 473 865091 alanscohen@skynet.be
Principal Investigator: László Solymosi, MD

Sponsors and Collaborators

Balt International

Investigators

Study Chair:

Jacques Moret, MD

Hôpital de la Fondation Rothschild (Paris, France)

More Information

No publications provided

Responsible Party:	Balt International ( Linda Nicolini / Director of Market Development )
ClinicalTrials.gov Identifier:	NCT01084681 History of Changes
Other Study ID Numbers:	Balt 2010-01
Study First Received:	March 8, 2010
Last Updated:	March 9, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Research Ethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Switzerland: Swissmedic; Israel: Ethics Commission; Turkey: Ethics Committee

Keywords provided by Balt International:

SILK flow diverter, intracranial stents, intracranial aneurysms

Additional relevant MeSH terms:

Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 01, 2010