Trial to evaluate the safety and efficacy of NOVUS stent graft in patients with abdominal aortic aneurysms

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007283

Enrollment

Registered

2022-05-13

Start date

2022-04-12

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. Screening : Visit 1 Review patients medical history and clinical information: Symptom, Imaging CT or MRI, Included/Exclusion criteria qualification, Physical exa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Common criteria for selection are those aged 19 to under 90 who understand the purpose of the clinical trial and sign a written consent form voluntarily. In fusiform aneurysm, abdominal aortic aneurysm 5.0 cm or larger, 4-5 cm to 6 months, or at risk of rupture, can be registered in one of the study.

Exclusion criteria

Exclusion criteria: 1. Patients who do not want to be treated 2. Pregnant women 3. The diameter of the iliac artery is 15 Fr: < 5 mm, 18 Fr: < 6 mm, 21 Fr: < 7 mm

Design outcomes

Primary

Measure	Time frame
Percentage of people who survived without stent graft and cardiovascular complications	—

Secondary

Measure	Time frame
Target lesion re-treatment or aortic surgery; accompanied by cardiovascular complications (aortic, vascular-related death, myocardial infarction, severe vascular damage, major stroke, paraplegia);CT with stent graft complications	—

Countries

Korea, Republic of

Contacts

Public ContactYu Cheol Woong

Korea University Anam Hospital

Outcome results