Trial to evaluate the safety and efficacy of stent graft in patients with thoracic aortic dissection and aortic aneurysms
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007282
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 62
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endoleak (excluding type II) Occurrence rate
- Secondary Outcome Measures
Name Time Method major event Occurrence rate