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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952780
• Other study ID #: 1-2018-0081
• Status: Completed
• Start date: September 2, 2019
• Est. completion date: September 20, 2023

Study information

• Verified date: April 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

Prospective single-arm multicenter registry

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major adverse event	Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days	30 days
Secondary	Major adverse event	Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year	1 year
Secondary	Aneurysm-related death	All-cause death at 30 days	30 days
Secondary	Aneurysm-related death	All-cause death at 1 year	1 year
Secondary	Aneurysm-related death	Aneurysm-related death at 30 days	30 days
Secondary	Aneurysm-related death	Aneurysm-related death at 1 year	1 year
Secondary	Reintervention	Reintervention at 1 year	1 year
Secondary	Type I/III endoleaks	Type I/III endoleaks at 30 days	30 days
Secondary	Type I/III endoleaks	Type I/III endoleaks at 1 year	1 year
Secondary	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	1 year
Secondary	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	30 days
Secondary	Number of closure devices used for the closure of access sites.	Number of closure devices used for the closure of access sites.	30 days