Clinical trial NCT03952780: Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Official title: Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: abdominal aortic aneurysm
endovascular repair
stent graft
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with abdominal aortic aneurysm treated with INCRAFT stent graft

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.

Detailed description: Prospective single-arm multicenter registry

Eligibility criteria: 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

Primary outcomes:
measure: Technical success
timeFrame: At the end of the procedure
Secondary outcomes:
measure: Major adverse event
timeFrame: 30 days
measure: Major adverse event
timeFrame: 1 year
measure: Aneurysm-related death
timeFrame: 30 days
measure: Aneurysm-related death
timeFrame: 1 year
measure: Aneurysm-related death
timeFrame: 30 days
measure: Aneurysm-related death
timeFrame: 1 year
measure: Reintervention
timeFrame: 1 year
measure: Type I/III endoleaks
timeFrame: 30 days
measure: Type I/III endoleaks
timeFrame: 1 year
measure: Aneurysm-related event
timeFrame: 1 year
measure: All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
timeFrame: 30 days
measure: Number of closure devices used for the closure of access sites.
timeFrame: 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu
Study officials:
References: