Trial to evaluate the safety and efficacy of stent graft in patients with thoracic aortic dissection and aortic aneurysms

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007282

Enrollment

Registered

2022-05-13

Start date

2022-03-04

Completion date

Unknown

Last updated

2025-04-07

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, Procedure/Surgery : 1) Approach: Intravascular procedure is performed percutaneous through the approach of both femoral arteries. 2) Registration: Patient registration is performed pri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The common selection criteria are patients aged 19 or older who understand the purpose of the clinical trial and voluntarily agree and sign a written consent form. If this is satisfied and falls under any of A), B), C), D), and E), registration is possible. A) fusiform aneurysm (1) greater than 5.5 cm in diameter of thoracic aorta and (2) greater than 0.5 cm in size over 6 months from 4-5 cm or with associated clinical symptoms B) saccular aneurysm with risk of rupture C) A false aneurysm or aortic rupture D) aortic dissection (1) max aortic diameter greater than 4 cm (acute)/more than 6 cm (chronic) (2) substandard diameter or (A) ischemic symptoms of branched vessels (B) delamination (D) dynamic obstruction (D) cavity diameter greater than 22 mm (acute) E) Penetrating aortic ulcer (PAU) (1) Repeated, uncontrolled pain (2) With intramural hematoma in the thoracic aorta (3) Size of PAU >20mm in diameter or >10mm in depth

Exclusion criteria

Exclusion criteria: 1. Patients who do not want to be treated 2. Pregnant women 3. The diameter of the iliac artery is 18 Fr: < 6 mm, 21 Fr: < 7 mm 4. Severe calcification and angulation of iliac artery

Design outcomes

Primary

Measure	Time frame
Endoleak (excluding type II) Occurrence rate	—

Secondary

Measure	Time frame
major event Occurrence rate	—

Countries

Korea, Republic of

Contacts

Public ContactRha SeungWoon

Koera University Guro Hospital

swrha617@yahoo.co.kr+82-2-2626-3020

Outcome results