A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study
Korean Journal of Radiology
;
: 505-512, 2019.
Article
in English
| WPRIM
| ID: wpr-741413
ABSTRACT
OBJECTIVE:
We report the results of a pilot clinical study that evaluated the safety and efficacy of a newly-developed, retrievable flow diverter (FloWise; Taewoong Medical) for the treatment of internal carotid artery (ICA) aneurysm. MATERIALS ANDMETHODS:
A total of 10 patients were enrolled. Inclusion criteria were 1) unruptured aneurysm with a dome size of ≥ 8 mm and a neck size of ≥ 4 mm at the ICA, or 2) two or more unruptured aneurysms of any size able to be spanned by a single FloWise at the ICA. Co-primary effectiveness end points were technical success of FloWise placement, and a 50% or greater decrease in aneurysm volume at the 6-month follow-up angiogram. The primary safety end point was the new development of neurological deficits persisting for more than 1-month post-treatment.RESULTS:
Ten patients harboring 14 ICA aneurysms (median diameter, 9.4 mm; range, 2.3–31.0 mm) were enrolled between January 2016 and July 2017. FloWise placement was successful in all patients. There were no newly-developed neurological deficits during the 6-month clinical follow-up period. One patient did not receive follow-up imaging due to pregnancy. Nine patients with 12 aneurysms received a 6-month angiographic follow-up. Ten aneurysms (83.3%) showed decreases in volume greater than 50% (mean volume decrease, 82.8 ± 32.9%), of which 8 (66.7%, 95% confidence interval, 35.4–98.0%) showed complete occlusion. One patient was retreated due to mass symptom aggravation.CONCLUSIONS:
In this pilot study, FloWise appeared to be safe and effective for ICA aneurysm treatment. A prospective multicenter study to validate the effectiveness and safety of FloWise would be worthwhile.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Carotid Artery, Internal
/
Intracranial Aneurysm
/
Pilot Projects
/
Prospective Studies
/
Follow-Up Studies
/
Clinical Study
/
Aneurysm
/
Neck
Type of study:
Controlled clinical trial
/
Observational study
/
Prognostic study
Limits:
Humans
/
Pregnancy
Language:
English
Journal:
Korean Journal of Radiology
Year:
2019
Type:
Article
Similar
MEDLINE
...
LILACS
LIS