Abdominal Aortic AneurysmNCT03952780
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
An observational study of Abdominal Aortic Aneurysm, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Sep 2019to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with abdominal aortic aneurysm treated with INCRAFT stent graft
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu
Seoul
About this study
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.
Read the detailed description
Prospective single-arm multicenter registry
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal aortic aneurysm, endovascular repair, stent graft
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the procedure
Secondary outcomes (12)
Major adverse event
Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days
Measured: 30 days
Major adverse event
Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year
Measured: 1 year
Aneurysm-related death
All-cause death at 30 days
Measured: 30 days
Aneurysm-related death
All-cause death at 1 year
Measured: 1 year
Aneurysm-related death
Aneurysm-related death at 30 days
Measured: 30 days
Aneurysm-related death
Aneurysm-related death at 1 year
Measured: 1 year
Reintervention
Reintervention at 1 year
Measured: 1 year
Type I/III endoleaks
Type I/III endoleaks at 30 days
Measured: 30 days
Type I/III endoleaks
Type I/III endoleaks at 1 year
Measured: 1 year
Aneurysm-related event
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
Measured: 1 year
All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
All vascular complications at 30 days related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
Measured: 30 days
Number of closure devices used for the closure of access sites.
Number of closure devices used for the closure of access sites.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start2 Sep 2019
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952780
- Sponsor's protocol ID
- 1-2018-0081
- Status last verified
- Apr 2024
- First submitted
- 14 May 2019
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
- ClinicalTrials.gov ID
- NCT03952780
- Acronym / sponsor ID
- 1-2018-0081
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal aortic aneurysm, endovascular repair, stent graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective single-arm multicenter registry
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominal aortic aneurysm treated with INCRAFT stent graft
Key inclusion criteria (12 listed)
- 1. AAA with one of following indications
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
12 secondary outcomes
Major adverse event
Time frame: 30 days
Major adverse event
Time frame: 1 year
Aneurysm-related death
Time frame: 30 days
Aneurysm-related death
Time frame: 1 year
Aneurysm-related death
Time frame: 30 days
Aneurysm-related death
Time frame: 1 year
Reintervention
Time frame: 1 year
Type I/III endoleaks
Time frame: 30 days
Type I/III endoleaks
Time frame: 1 year
Aneurysm-related event
Time frame: 1 year
All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
Time frame: 30 days
Number of closure devices used for the closure of access sites.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: At the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.