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

NCT03952780 | Completed

• 1 other identifier: 1-2018-0081
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal aortic aneurysm; endovascular repair; stent graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Major adverse event

  30 days

• Major adverse event

  1 year

• Aneurysm-related death

  30 days

• Aneurysm-related death

  1 year

• Aneurysm-related death

  30 days

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with abdominal aortic aneurysm treated with INCRAFT stent graft

You may qualify if:

• \. 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.
• \. Proximal aortic neck length ≥10 mm with a diameter ≥ 17 and ≤ 31 mm in combination with supra- and infrarenal angulation ≤ 60 degree.
• \. Iliac landing zone with a length ≥15 mm and a diameter ≥ 7 and ≤ 22 mm
• \. Femoral access vessels should be adequate to fit the selected delivery system
• \. Minimum overall AAA treatment length (proximal landing location to distal landing location to distal landing location) ≥128 mm
• \. Aortic bifurcation \>18 mm in diameter
• \. Patents with age of 19-80 years.
• \. Male or non-pregnant female
• \. Voluntary participation in the study with signed informed consent form.

You may not qualify if:

• \. Dissecting or ruptured abdominal aortic aneurysm
• \. Presence of connective tissue disease (Marfan's syndrome or Ehlers-Danlos syndrome).
• \. Prior AAA or iliac artery repair
• \. Active infection or active vasculitis.
• \. Myocardial infarction or cerebrovascular accident within 3 months prior to study enrolment.
• \. Need for renal artery coverage (e.g. Chimney graft)
• \. Dialysis-dependent renal failure or serum creatinine \>2.0 mg/dl
• \. Intolerance/hypersensitivity to contrast media or antiplatelet drugs.
• \. Positive pregnancy test.
• \. Participation in another medical research study within 1 month of study enrolment.
• \. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
• \. Patients with life expectancy less than 1 year

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: September 2, 2019
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)