Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

June 7, 2011 updated by: Balt International

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)

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Wuerzburg, Germany, 97080
        • Recruiting
        • Universitätsklinikum Würzburg; Abteilung für Neuroradiologie
        • Contact:
        • Contact:
        • Principal Investigator:
          • László Solymosi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.
Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.
Other Names:
  • Endovascular treatment of intracranial aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 12 months

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.

12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jacques Moret, MD, Beaujon Hospital - Paris Diderot University (Paris, France)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intracranial Aneurysms

Clinical Trials on Endovascular treatment of intracranial aneurysms

3
Subscribe