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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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

, ,

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

, ,

Verification Date

May 2019