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Postoperative endovascular intervention for false lumen for aortic dissection (FL intervention)

False lumen intervention (FL intervention)

8

Median age was 76 (71-78) years, 5 (62.5%) males and 3 (37.5%) females. Six patients (75%) had Stanford type A dissection and two (25%) had type B. Median systolic blood pressure was 124 mm Hg (118-131), median pulse rate was 62 beats/min (60-66), median hemoglobin level was 13.2 g/dl (12.2-13.8), median creatinine was 0.95 mg/dl (0.82-1.21), median eGFR was 52 mL/min/1.73m^2 (46.6-60.9) and median FDP was 27micro-g/mL (13.8-38.8). The median maximum diameter of the aortic aneurysm was 57 mm (51-62), and the patency of the false lumen was partially thrombosed in 7 patients (87.5%) and patent in 1 patient (12.5%).

Enrollment was low compared to the originally anticipated pace, with only 8 patients enrolled. All 8 patients completed endovascular treatment as specified in the protocol; 2 deaths occurred during the 2-year follow-up, but were not related to the study device and treatment.

During the study period, cerebral infarction in 1, subarachnoid hemorrhage in 1, and aspiration pneumonia in 1 patient occurred. These complications were not related to the study device or treatment.

In this study, the primary endpoint was the aortic aneurysm diameter by CT 12 months after treatment with the study device, and whether endovascular treatment with the study device resulted in a reduction in aortic aneurysm diameter was tested. Results showed a median shrinkage of 14% (4.4-20%) in the diameter at 12 months. The patients were also followed up at 24 months with a good median shrinkage of 15.4% (0-27%).

In patients with enlarged false lumen after endovascular repair of graft replacement for aortic dissection, we confirmed the safety and efficacy of using a small-diameter stent graft insertion to close the entry using a test device to prevent the sac enlargement or the false lumen shrinkage.

Nov. 18, 2025

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs052190096

Matsuda Hitoshi

National Cerebral and Cardiovascular Center

6-1 Kishibeshinmachi, Suita, Osaka

hitmat@mist.ocn.ne.jp

Seike Yoshimasa

National Cerebral and Cardiovascular Center

6-1 Kishibeshinmachi, Suita, Osaka

+81-6-6170-1070

ys46421g@ncvc.go.jp

Complete

Jan. 27, 2020

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

Patients who had past history of undergoing the surgery for aortic dissection.
Patients who developed aortic dilation more than 45mm in thoracic aortic aneurysm or more than 40mm in abdominal aortic aneurysm.
Patients who developed rapid aortic dilation more than 3mm in 6 months or more than 5mm in 12months.

Patients who had systemic infection that may increase the risk of device-related infection.
Patients who are allergic to the material of the device.
Pregnant women, lactating women or women who cannot agree on contraception during participating in this study.

Both

Dissecting aneurysm of the aorta

Entry closure located at the orifice including the neck vessels, visceral arteries, and the iliac arteries.

Stanford classification, Aortic remodeling

Entry closure

I710

Aortic diameter on CT at 12 months after intervention.

Occlusive condition of the false lumen 12 months after intervention.
Aortic diameter on CT and occlusive condition of the false lumen 6 and 24 months after intervention.
Freedom from aortic rupture, re-aortic dissection, sudden death, and secondary intervention

+81-78-382-6669

Jan. 20, 2020

Japan