- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03952780
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
April 3, 2024 updated by: Yonsei University
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Prospective single-arm multicenter registry
Study Type
Observational
Enrollment (Actual)
86
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu
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Contact:
- Donghoon Choi, MD, PhD.
- Phone Number: 82-2-2228-8460
- Email: cdhlyj@yuhs.ac
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with abdominal aortic aneurysm treated with INCRAFT stent graft
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At the end of the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse event
Time Frame: 30 days
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Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days
|
30 days
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Major adverse event
Time Frame: 1 year
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Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year
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1 year
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Aneurysm-related death
Time Frame: 30 days
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All-cause death at 30 days
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30 days
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Aneurysm-related death
Time Frame: 1 year
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All-cause death at 1 year
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1 year
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Aneurysm-related death
Time Frame: 30 days
|
Aneurysm-related death at 30 days
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30 days
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Aneurysm-related death
Time Frame: 1 year
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Aneurysm-related death at 1 year
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1 year
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Reintervention
Time Frame: 1 year
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Reintervention at 1 year
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1 year
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Type I/III endoleaks
Time Frame: 30 days
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Type I/III endoleaks at 30 days
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30 days
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Type I/III endoleaks
Time Frame: 1 year
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Type I/III endoleaks at 1 year
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1 year
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Aneurysm-related event
Time Frame: 1 year
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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
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1 year
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All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
Time Frame: 30 days
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All vascular complications at 30 days related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
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30 days
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Number of closure devices used for the closure of access sites.
Time Frame: 30 days
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Number of closure devices used for the closure of access sites.
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2019
Primary Completion (Actual)
September 20, 2023
Study Completion (Actual)
September 20, 2023
Study Registration Dates
First Submitted
May 14, 2019
First Submitted That Met QC Criteria
May 14, 2019
First Posted (Actual)
May 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 3, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2018-0081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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