Clinical Study for Fenestrated Aortic Arch Stent Graft with Preloading Catheter to Save Branch Artery: One Branch Type

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0003868
• Lead Sponsor: S&G Biotech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

All of the following criteria must be met to enroll in this trial.
In the case of Selection Criteria 1, the selection criterion satisfies the selection criterion 1 even if only one of the criteria 1) to 10) satisfying Euroscore> 6% or more than 60 years of age is applied.

1. EuroSCORE> 6% of those aged 70 or older, or those aged 60 or older who have one or more of the following risk ailments
1) liver cirrhosis
2) pulmonary dysfunction (FEV1 <1L)
3) previous heart surgery
4) Severe pulmonary hypertension (60mmHg)
5) Severe aortic calcification (porcelain aorta)
6) Repetitive pulmonary embolism
7) Heart failure (Ejection fraction <40%)
8) If thoracic burn or mediastinal surgery is not possible with radiation therapy
9) Severe connective tissue disease is impossible.
10) Severe weight loss patients (Body mass index <18 kg / m2)
11) Inability of surgery due to multiple trauma
12) If surgery is not possible due to bleeding tendency

2. Patients with thoracic aortic aneurysms: diameter greater than 55 mm or complications
1) Proximal attachment point 0-15mm (Proximal neck 0-15mm)
-> The distance from the left subclavian artery to the rupture area of ??the aortic dissection is 0-15 mm
2) Location of aortic aneurysms:
A. The procedure is performed when the lesion is located on the inner side of the aorta or on the side (lesser curvature or lat wall).
B. In the case of greater curvature of the aorta, a proximal neck of 10 mm or more
The procedure is performed.
3) The procedure is performed when the distance from the highest part of the aortic arch to the subclavian artery is less than 25mm.
(Length from top of aortic arch to lateral wall of left subclavian artery= 25 mm, Fig.A)
4) Diameter of iliac artery is=7mm in case of 20 Fr., 22Fr. If the case= 8mm or more is performed.
(Iliac artery diameter 20 Fr:= 7 mm, 22 Fr:= 8 mm)

3. Patients with descending aortic dissection with complications
1) Proximal attachment point 0-15mm (Proximal neck 0-15mm)
-> The distance from the left subclavian artery to the rupture area of ??the aortic dissection is 0-15 mm
2) Location of aortic rupture:
A. If the lesion is located on the inside of the aorta or on the side (lesser curvature or lat wall)
B. In the case of greater curvature of the aorta, a proximal neck of 10 mm or more
The procedure is performed.
3) The procedure is performed when the distance from the highest part of the aortic arch to the subclavian artery is less than 25mm.
(Length from top of aortic arch to lateral wall of left subclavian artery = 25 mm, Fig.A)
4) Diameter of iliac artery is= 7mm in case of 20 Fr., 22Fr. If the case= 8mm or more is performed.
(Iliac artery diameter 20 Fr:= 7 mm, 22 Fr:= 8 mm)

4. Traumatic aortic dissection with complications
1) Proximal attachment point 0-15mm (Proximal neck 0-15mm)
-> The distance from left subclavian artery to traumatic aortic dissection is 0-15 mm
2) Location of aortic dissection:
A. If the lesion is located on the inside of the aorta or on the side (lesser curvature or lat wall)
B. In the case of greater curvature of the aorta, a proximal neck of 10 mm or more
The procedure is performed.
3) The procedure is performed when the distance from the highest part of the aortic arch to the subclavian artery is less than 25mm.
(Length from top of aortic arch to lateral wall of left subclavian artery = 25 mm, Fig.A)
4) Diameter of iliac artery is=7mm in case of 20 Fr., 22Fr. If the case= 8mm or more

Exclusion Criteria

Any of the following exclusion criteria will be excluded from this trial.

1. The distance from the left subclavian artery to the lesion is not less than 15mm.
2. Intraoperative stent graft The diameter of the iliac artery is 24 mm-36 mm. The diameter of the iliac artery is 7 mm or less. The diameter of the iliac artery is less than 8 mm for the stent graft diameter of 38 mm-46 mm. do.
Stent graft diameter
(stent graft diameter) 24-36mm 38-46mm
Iliac artery diameter
(iliac artery diameter 7mm or more and 8mm or more

3. Severe calcification and angulation of iliac artery.
4. The distance from the highest part of the aortic arch to the subclavian artery is 25 mm or more.
(Length from top of aortic arch to lateral wall of left subclavian artery> 25 mm)
5. The location of the aortic disease is greater in the curvature of the aorta and the proximal neck is less than 10 mm
6. If the diameter of the proximal neck of the aorta exceeds 44 mm, the maximum diameter of the open-type stent graft, 46 mm, can not be performed.
7. Uncontrolled hypertension
8. Unadjusted diabetes (Hb A1c> 10)
9. Pregnant women and lactating women (If the woman is not pregnant,
10. Patients who do not want to be treated

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(cumulative survival)

Secondary Outcome Measures

Name	Time	Method
Target lesion re-treatment up to 12 months after the procedure;Aortic Surgery;Cardiovascular complications;Complications of stent graft in CT