Clinical Study of Thoracic Endovascular Repair for Aortic Arch Aneurysms with Surgeon-Modified Fenestrated and Retrograde Branched Device

Clinical Study of Thoracic Endovascular Repair for Aortic Arch Aneurysms with Surgeon-Modified Fenestrated and Retrograde Branched Device - Clinical Study of Thoracic Endovascular Repair for Aortic Arch Aneurysms with Surgeon-Modified Fenestrated and Retrograde Branched Device

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020057

Enrollment

Registered

2015-12-03

Start date

2015-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Arch or Distal Arch Aneurysms

Interventions

Treat aortic arch aneurysms with surgeon-modified fenestrated and retrograde branched stent graft and follow up with patients for 12 months post-operatively.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aortic arch fusiform aneurysm with diameter >50 mm 2) Aortic arch fusiform aneurysm with a history of growth >5 mm per year 3) Aortic arch saccular aneurysm with 1.5 times the diameter as compared to the normal size

Exclusion criteria

Exclusion criteria: <General Exclusion Criteria> 1) Less than 20 years of age 2) Pregnant or patients likely to have been pregnant 3) Life expectancy less than 1 years 4) Unwilling to company with the follow up schedule 5) Inability or refusal to give informed consent *Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too.

Design outcomes

Primary

Measure	Time frame
The rates of aortic disease related death at 12 months post-procedure	—

Secondary

Measure	Time frame
Device Success, Procedural Time, Condit Usage During The Procedure, Clinical Utility Measures, Morbidity, Including The Composite Rate Of Major Adverse Events, Endoleak, Change In Aneurysm Size, Migration, Device Patency, Device Integrity	—

Countries

Japan

Contacts

Public ContactSatoshi Satoshi

Shimane Prefectural Central Hospital Department of Cardiovascular Surgery

kamihira@spch.izumo.shimane.jp0853-22-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026