A prospective multicenter, open, single design, commercial trial to evaluate the safety and efficacy of NOVUS stent graft in patients with abdominal aortic aneurysm (AAA)

Not Applicable

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0008585
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 August 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Common Selection Criteria
- Adults between the ages of 19 and 90 who understand the purpose of the clinical trial, voluntarily consent, and sign a written consent form
2. Fusiform aneurysm
- Abdominal aortic aneurysm more than 5.0 cm in diameter
- If the diameter increases by more than 0.5cm in 6 months from 4-5cm in diameter or there are related clinical symptoms
3. Saccular aneurysm at risk of rupture
4. Pseudoaneurysm or aortic rupture
5. PAU (more than 2cm in width and more than 1cm in depth)
- Selection criterion 1 must be satisfied, and only patients with one of the diseases of selection criteria 2, 3, 4, and 5 can be enrolled.

Exclusion Criteria

1. Patients who do not want the procedure
2. Pregnant women
3. Diameter of the iliac artery < 5 mm when using a 15 Fr device, < 6 mm when using an 18 Fr device, and < 7 mm when using a 21 Fr device

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Proportion of survivors without stent graft and cardiovascular complications

Secondary Outcome Measures

Name	Time	Method
In case of target lesion re-operation or major camellia surgery; Cardiovascular complications (aorta, vascular-related death, myocardial infarction, major vascular damage, major stroke, paraplegia; In case of complication of stent graft in CT