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

NCT03952780 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2024-04-05

No results posted yet for this study

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2023-09-20
Completion
2023-09-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03952780 on ClinicalTrials.gov