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

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ClinicalTrials.gov Identifier: NCT03952780
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease
Abdominal Aortic Aneurysm

Detailed Description:
Prospective single-arm multicenter registry

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with abdominal aortic aneurysm treated with INCRAFT stent graft
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952780


Locations
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Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu Not yet recruiting
Seoul, Korea, Republic of
Contact: Donghoon Choi, MD, PhD.    82-2-2228-8460    cdhlyj@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03952780     History of Changes
Other Study ID Numbers: 1-2018-0081
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:
abdominal aortic aneurysm
endovascular repair
stent graft

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases