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Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

Primary Purpose

Intracranial Aneurysms

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endovascular treatment of intracranial aneurysms
Endovascular treatment of intracranial aneurysm with coils
Sponsored by
Balt International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysms focused on measuring SILK flow diverter, intracranial stents, intracranial aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitätsklinikum Würzburg; Abteilung für NeuroradiologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SILK Artery Reconstruction Device

Coils

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 8, 2010
Last Updated
June 7, 2011
Sponsor
Balt International
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1. Study Identification

Unique Protocol Identification Number
NCT01084681
Brief Title
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Balt International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms
Keywords
SILK flow diverter, intracranial stents, intracranial aneurysms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SILK Artery Reconstruction Device
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Coils
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endovascular treatment of intracranial aneurysms
Intervention Description
Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
Intervention Type
Device
Intervention Name(s)
Endovascular treatment of intracranial aneurysm with coils
Other Intervention Name(s)
Endovascular treatment of intracranial aneurysms
Intervention Description
Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.
Primary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Nicolini, MBA
Phone
+33 1 39894641
Email
linda.nicolini@balt.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Cohen, BS
Phone
+32 473 865091
Email
alanscohen@skynet.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Moret, MD
Organizational Affiliation
Beaujon Hospital - Paris Diderot University (Paris, France)
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinikum Würzburg; Abteilung für Neuroradiologie
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Nicolini, MBA
Phone
+33 1 39894641
Email
linda.nicolini@balt.fr
First Name & Middle Initial & Last Name & Degree
Alan Cohen, BS
Phone
+32 473 865091
Email
alanscohen@skynet.be
First Name & Middle Initial & Last Name & Degree
László Solymosi, MD

12. IPD Sharing Statement

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Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

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