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The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm. This study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. A total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of INCRAFT stent graft. The primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. The primary safety outcome is major vascular complications at 30 days including. The study subjects will be followed for 12 months.
Prospective single-arm multicenter registry
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| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. Primary conversion or additional implantation of bare metal stent, aortic cuff or EndoAnchors to treat type I endoleak is considered a technical failure. | At the end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse event | Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days | 30 days |
| Major adverse event | Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year |
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Inclusion Criteria:
1. AAA with one of following indications
2. Proximal aortic neck length ≥10 mm with a diameter ≥ 17 and ≤ 31 mm in combination with supra- and infrarenal angulation ≤ 60 degree.
3. Iliac landing zone with a length ≥15 mm and a diameter ≥ 7 and ≤ 22 mm
4. Femoral access vessels should be adequate to fit the selected delivery system
5. Minimum overall AAA treatment length (proximal landing location to distal landing location to distal landing location) ≥128 mm
6. Aortic bifurcation >18 mm in diameter
7. Patents with age of 19-80 years.
8. Male or non-pregnant female
9. Voluntary participation in the study with signed informed consent form.
Exclusion Criteria:
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Patients with abdominal aortic aneurysm treated with INCRAFT stent graft
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu | Seoul | South Korea |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 year |
| Aneurysm-related death | All-cause death at 30 days | 30 days |
| Aneurysm-related death | All-cause death at 1 year | 1 year |
| Aneurysm-related death | Aneurysm-related death at 30 days | 30 days |
| Aneurysm-related death | Aneurysm-related death at 1 year | 1 year |
| Reintervention | Reintervention at 1 year | 1 year |
| Type I/III endoleaks | Type I/III endoleaks at 30 days | 30 days |
| Type I/III endoleaks | Type I/III endoleaks at 1 year | 1 year |
| Aneurysm-related event | Aneurysm-related event (aneurysm-related death, reintervention, and aorta expansion> 5 mm, device migration, conversion to open repair, stent graft fracture, stent graft occlusion) at 1 year | 1 year |
| All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions | All vascular complications at 30 days related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions | 30 days |
| Number of closure devices used for the closure of access sites. | Number of closure devices used for the closure of access sites. | 30 days |
| D001018 |
| Aortic Diseases |