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Multicenter prospective randomized trial of aneurysm sac side branch embolization during endovascular aneurysm repair

Multicenter prospective randomized trial of aneurysm sac side branch embolization during endovascular aneurysm repair - RCT of Side Branch Embolization during EVAR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051653
Enrollment
90
Registered
2023-09-01
Start date
2023-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Interventions

Control group: Regular EVAR + IMA embolization for patients with patent inferior mesenteric artery (IMA) Aneurysmal sac side branch (ASSB) prophylactic embolization group: Regular EVAR + embolization

Sponsors

Nagoya University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 18 years of age or older with spindle-shaped abdominal aortic aneurysm indicated for surgery (maximum short-axis diameter >50 mm or rapid enlargement >5 mm/6 months) and judged to be eligible for standard EVAR at each institution. Patients who understand the study and give written consent. Patients must be eligible from the date of study approval to March 31, 2026.

Exclusion criteria

Exclusion criteria: Patients whose all lumbar arteries at the aneurysm site are occluded. Subjects with systemic conditions or advanced malignancies that are expected to have a life expectancy of less than 1 year. Patients with known hereditary diseases such as Marfan syndrome or Ehlers-Danlos syndrome Infected aortic aneurysm Isolated iliac artery aneurysm Patients with isolated iliac artery aneurysm, isolated iliac artery aneurysm, cystic aneurysm, or PAU (penetrating atherosclerotic ulcer). Patients with severe allergy to iodine contrast media who cannot use contrast media Patients with renal impairment with preoperative eGFR less than 30 ml/min/1.73 m2 and not on dialysis Women who are pregnant, possibly pregnant, within 28 days postpartum, or lactating.

Design outcomes

Primary

MeasureTime frame
One-year aneurysm sac shrinkage after EVAR

Secondary

MeasureTime frame
Two- / Three-year sac shrinkage after EVAR, Incidence of type II endoleaks, Overall survival, Freedom from aneurysm-related death, Freedom from re-intervention

Countries

Japan

Contacts

Public ContactYayoi Furuta

Nagoya University Graduate School of Medicine Division of Vascular and Endovascular Surgery, Department of Surgery

yfuruta@med.nagoya-u.ac.jp052-744-2224

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026