LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy

Stopped early · Phase 4

Conditions studied: Intracranial Aneurysm

In brief

In this study, patients with large anterior circulation IAs with neck and fundus morphologies amenable to either traditional endovascular treatments using coils or reconstruction with the flow diversion will be randomly assigned to either treatment technique.

Key facts

Study ID

NCT01762137

Run by

Medical University of South Carolina

People needed

23

Starts

2013-02-01

Expected to finish

2017-02-01

Last updated by the study team

2018-02-13

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21 to 75 years, inclusive
• Patient has a single target IA that: is located in the following regions of the internal carotid artery:
• Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments)
• Cavernous
• Petrous
• has a parent vessel with diameter 2.5-5.0 mm
• Wide neck aneurysm ≥4 mm.
• Target IA has size (maximum fundus diameter) 10 mm
• The operator feels that the aneurysm can be appropriately treated with traditional endovascular techniques (endovascular coil embolization with or without adjunctive devices or parent artery deconstruction) using endovascular coiling or flow diversion devices.
• Modified Rankin Scale 0-3
• Signed and dated informed consent
• 2 Exclusion criteria
• More than one IA requiring treatment in the next 6 months
• Subarachnoid hemorrhage in the past 60 days
• Any intracranial hemorrhage in the last 42 days
• Major surgery (requiring general anesthesia) in the last 42 days
• Coils in place in the target IA
• Unstable neurologic deficit (i.e., any rapidly worsening clinical condition in the last 30 days (defined by a change in mRS of 2 or more))
• Known irreversible bleeding disorder
• Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
• Clinically documented evidence in medical history of adverse reaction or contraindication to medications used in treatment of the aneurysm (i.e. Plavix, heparin, aspirin)
• Prior stent placement at target site
• Documented history of dementia
• Contraindication to CT scan and MRI (ie. contrast allergy, or other condition that prohibits imaging from either CT or MRI)
• Known allergy to contrast used in angiography that cannot be medically controlled

Where it is running

• MUSC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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