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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01762137
• Date of registration: 16/11/2012
• Prospective Registration: Yes
• Primary sponsor: Medical University of South Carolina
• Public title: LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy LARGE
• Scientific title: LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy
• Date of first enrolment: February 2013
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01762137
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Aquilla Turk, DO
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion criteria

1. Age 21 to 75 years, inclusive

2. Patient has a single target IA that: is located in the following regions of the
internal carotid artery:

1. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments)

2. Cavernous

3. Petrous

3. has a parent vessel with diameter 2.5-5.0 mm

4. Wide neck aneurysm =4 mm.

5. Target IA has size (maximum fundus diameter) 10 mm

6. 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.

7. Modified Rankin Scale 0-3

8. Signed and dated informed consent

4.2 Exclusion criteria

1. More than one IA requiring treatment in the next 6 months

2. Subarachnoid hemorrhage in the past 60 days

3. Any intracranial hemorrhage in the last 42 days

4. Major surgery (requiring general anesthesia) in the last 42 days

5. Coils in place in the target IA

6. 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))

7. Known irreversible bleeding disorder

8. Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction

9. Clinically documented evidence in medical history of adverse reaction or
contraindication to medications used in treatment of the aneurysm (i.e. Plavix,
heparin, aspirin)

10. Prior stent placement at target site

11. Documented history of dementia

12. Contraindication to CT scan and MRI (ie. contrast allergy, or other condition that
prohibits imaging from either CT or MRI)

13. Known allergy to contrast used in angiography that cannot be medically controlled

14. Known severe allergy to platinum or cobalt/chromium alloys

15. Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)

16. Pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] (Woman
of child-bearing potential must have a negative pregnancy test prior to the study
procedure.)

17. Evidence of active infection (indicated by fever [at or over 99.9 °F] and/or open
draining wound) at the time of randomization

18. Other known conditions of the heart, blood, brain or intracranial vessels that carry a
high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known
carotid stenosis)

19. Current use of cocaine or other illicit substance

20. Any comorbid disease or condition expected to compromise survival or ability to
complete Follow-up assessments through 180 days

21. Extracranial stenosis greater than 50% in the carotid artery

22. Intracranial stenosis greater than 50% in the treated vessel

23. Based on investigator's judgment, patient does not have the necessary mental capacity
to participate or is unwilling or unable to comply with protocol follow up appointment
schedule.

24. "Previously randomized into this trial or currently participating in another trial
where the data is intended to be used to obtain marketing approval or to broaden an
indication, without the approval of the study principal investigator, that may
confound the results of this study.

A screen failure log of all cases referred or presented for possible inclusion, but who
were not randomized, and the reason(s) for exclusion will be maintained.



Age minimum: 21 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Intracranial Aneurysm

Intervention(s)

Procedure: Flow Diversion

Procedure: Coiling

Primary Outcome(s)

The primary aim of aneurysm treatment is to achieve occlusion of the IA without morbidity or mortality. [Time Frame: approaximately 180 days after aneurysm treatement procedure]

Secondary Outcome(s)

Incidence of device or procedure related adverse events at 180 days, 1 year and 3 years. [Time Frame: 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. [Time Frame: approximately 3 years after aneurysm treatment procedure]

Subgroup analysis of clinical and angiographic outcomes in aneurysms reconstructive vs. deconstructive technique. [Time Frame: approximately 3 years after aneurysm treatment procedure]

Packing density as measured by volumetric filling of the aneurysm if aneurysm is coiled. [Time Frame: after initial procedure, day 0]

Procedure time, as measured as the time from placement of the treating guide catheter for purposes of aneurysm treatment until guide catheter removal. [Time Frame: approximately 6 years after the initial procedure]

Subgroup analysis of clinical and angiographic outcomes in aneurysms intradural vs. extradural location [Time Frame: approximately 3 years after aneurysm treatment procedure]

Device cost of therapy at treatment and any subsequent retreatment. [Time Frame: approximately 6 years after the initial 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. [Time Frame: 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. [Time Frame: 180 days]

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. [Time Frame: approaximately 180 days, 1 year, and 3 years after aneurysm treatement procedure]

Number of inpatient hospital (and re-hospitalized) days (subgrouped >7 days) at 180 days, 1 year and 3 years. [Time Frame: 180 days, 1 year and 3 years.]

Secondary ID(s)

PRO18426

Source(s) of Monetary Support

Please refer to primary and secondary sponsors