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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008585

Enrollment

Registered

2023-06-29

Start date

2024-01-12

Completion date

Unknown

Last updated

2026-07-13

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: 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

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

Design outcomes

Primary

Measure	Time frame
Proportion of survivors without stent graft and cardiovascular complications	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactHOJONG CHUN

The Catholic University of Korea, Seoul St. Mary's Hospital

hojongchun@gmail.com+82-2-2258-1456

Outcome results