Brief Title
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Official Title
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Brief Summary
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
Prospective single-arm multicenter registry
Study Type
Observational
Primary Outcome
Technical success
Secondary Outcome
Major adverse event
Condition
Abdominal Aortic Aneurysm
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
100
Start Date
June 2019
Completion Date
August 2022
Primary Completion Date
August 2022
Eligibility Criteria
Inclusion Criteria: - 1. AAA with one of following indications 1. AAA with maximum diameter > 5 cm, 2. AAA with maximum diameter > 4 cm with an increase >0.5 cm during the preceding 6 months 3. 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
Gender
All
Ages
19 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03952780
Organization ID
1-2018-0081
Responsible Party
Sponsor
Study Sponsor
Yonsei University
Study Sponsor
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Verification Date
May 2019