A prospective multicenter, open, single design, commercial trial to evaluate the safety and efficacy of stengrafting in patients with thoracic aortic dissection and aortic aneurysms

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005776

Enrollment

Registered

2021-01-13

Start date

2020-12-24

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

None listed

Interventions

Medical Device : evaluate the safety and efficacy of S&G stent grafting in patients with thoracic aortic dissection and aortic aneurysms

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Common Selection Criteria - Adults between the ages of 20 and 90 who understand the purpose of clinical trials and sign written consent forms voluntarily 2. Aortic aneurysm - thoracic aortic aneurysm diameter of 5.5 cm or more, abdominal aortic aneurysm diameter of 5.0 cm or more - increasing in size or relating to more than 0.5 cm in 6 months from 4–5 cm in the presence of symptoms 3. Provisional aneurysm or aortic aneurysm 4. Aortic detachment - When the maximum aortic diameter is 4 cm or more (acute) Or 6cm or more (chronic) - below-standard diameter or (a) Cases of ischemic syndrome of branched blood vessels (B) in the case of progress of detachment (C) With Dynamicsobstruction

Exclusion criteria

Exclusion criteria: 1. Patients who do not want treatment 2. Pregnant women 3. If the diameter of the iliac artery is 18Fr:<6mm, 21Fr:<7mm 4. When the iliac artery is severely calcified and bent (Severe calcification and angulation of iliac artery)

Design outcomes

Primary

Measure	Time frame
Rules for the occurrence of abnormal reaction of medical devices for 6 months after operation	—

Secondary

Measure	Time frame
aorta-related death;adverse event;technical success	—

Countries

Korea, Republic of

Contacts

Public ContactMINGYU LEE

S&G Biotech

2mingyuuu@naver.com+82-31-748-6625

Outcome results