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

NCT01762137 | Terminated Phase 4 DMC

• 1 other identifier: PRO18426
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Aneurysm

Keywords

Aneurysm; Coiling; Flow Diversion

Outcome Measures

Primary Outcomes (1)

• The primary aim of aneurysm treatment is to achieve occlusion of the IA without morbidity or mortality.

  Greater than 90% angiographic occlusion AND stable (or decreased) aneurysm size on cross sectional imaging (CT or MR) at 180 days post procedure. The primary objective is to show that flow diversion is non-inferior to endovascular coiling with respect to a combined efficacy and safety endpoint.

  approaximately 180 days after aneurysm treatement procedure

Secondary Outcomes (11)

• Incidence of device or procedure related adverse events at 180 days, 1 year and 3 years.

  approximately 90 days, 180 days, 1 year, 2 year and 3 year

• Subgroup analysis of clinical and angiographic outcomes in aneurysms 10-20 mm and > 2 cm.

  approximately 3 years after aneurysm treatment procedure

• Downstream flow related ischemic stroke, parenchymal hemorrhage, subarachnoid hemorrhage, aneurysm rupture or re-treatment of index aneurysm rates at 180 days, one year and 3 years.

  approaximately 180 days, 1 year, and 3 years after aneurysm treatement procedure

• Change in clinical functional outcome at 180 days, 1 year and 3 years post-endovascular treatment procedure, as measured by an increase in the modified Rankin Scale from baseline.

  180 days, 1 year and 3 years post-endovascular treatment procedure

• Incidence of worsening of baseline neurological signs/symptoms as measured by NIHSS/ophthalmologist exam related to target intracranial aneurysm (IA) at 180 days.

  180 days

Study Arms (2)

Coiling

ACTIVE COMPARATOR

Coiling

Procedure: Coiling

Flow Diversion

ACTIVE COMPARATOR

Flow Diversion

Procedure: Flow Diversion

Interventions

Flow Diversion PROCEDURE

Endovascular flow diverter placement

Flow Diversion

Coiling PROCEDURE

Endovascular coil placement

Coiling

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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
• Known severe allergy to platinum or cobalt/chromium alloys
• Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

MUSC

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aquilla Turk, DO

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: January 7, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

US (1)