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Completed

NCT Number: NCT03952780

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

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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu

Seoul, South Korea

About this study

Prospective single-arm multicenter registry

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Technical success

    Time frame: At the end of the procedure

    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.

Secondary outcomes

  1. Major adverse event

    Time frame: 30 days

    Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days

  2. Major adverse event

    Time frame: 1 year

    Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year

  3. Aneurysm-related death

    Time frame: 30 days

    All-cause death at 30 days

  4. Aneurysm-related death

    Time frame: 1 year

    All-cause death at 1 year

  5. Aneurysm-related death

    Time frame: 30 days

    Aneurysm-related death at 30 days

  6. Aneurysm-related death

    Time frame: 1 year

    Aneurysm-related death at 1 year

  7. Reintervention

    Time frame: 1 year

    Reintervention at 1 year

  8. Type I/III endoleaks

    Time frame: 30 days

    Type I/III endoleaks at 30 days

  9. Type I/III endoleaks

    Time frame: 1 year

    Type I/III endoleaks at 1 year

  10. Aneurysm-related event

    Time frame: 1 year

    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

  11. All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions

    Time frame: 30 days

    All vascular complications at 30 days related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions

  12. Number of closure devices used for the closure of access sites.

    Time frame: 30 days

    Number of closure devices used for the closure of access sites.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 16, 2019
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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