Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)

Study Overview
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Brief Summary
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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.

Detailed Description
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Prospective single-arm multicenter registry

Official Title
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Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)

Conditions
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Abdominal Aortic Aneurysm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. AAA with one of following indications AAA with maximum diameter > 5 cm, AAA with maximum diameter > 4 cm with an increase >0.5 cm during the preceding 6 months Saccular type AAA irrespective of the sac diameter. 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: 1. Dissecting or ruptured abdominal aortic aneurysm 2. Presence of connective tissue disease (Marfan's syndrome or Ehlers-Danlos syndrome). 3. Prior AAA or iliac artery repair 4. Active infection or active vasculitis. 5. Myocardial infarction or cerebrovascular accident within 3 months prior to study enrolment. 6. Need for renal artery coverage (e.g. Chimney graft) 7. Dialysis-dependent renal failure or serum creatinine >2.0 mg/dl 8. Intolerance/hypersensitivity to contrast media or antiplatelet drugs. 9. Positive pregnancy test. 10. Participation in another medical research study within 1 month of study enrolment. 11. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment. 12. Patients with life expectancy less than 1 year

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal aortic aneurysm, endovascular repair, stent graft