A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)

INNER-B-APAC - Asian Pacific Post-market Clinical Follow-up Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System

The INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with thoracoabdominal aortic aneurysms.

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracoabdominal Aortic Aneurysm

Detailed Description

In this study, patients will be observed who are planned to be treated an E-nside TAAA Multibranch Stent Graft System for endovascular repair of a degenerative, atherosclerotic thoracoabdominal aortic aneurysm. The E-nside TAAA Multibranch Stent Graft will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-nside TAAA Multibranch Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. Patient data will be documented in an eCRF at the following time points: Pre-operative planning, intervention(s), discharge(s) from hospital, 30 days, 3-6 and 12 months follow-up. The period of data collection will be approximately 12 months (depending on the time point of the 12 months FU visit) from the index procedure for each patient. A 100% source data verification will be performed regarding patient information and consent, criteria of patients to be documented, pre-operative planning, intervention(s), treatment results, adverse events, death, and reintervention. Complete DICOM image files of the CT scans will be sent to a CoreLab for independent second evaluation.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia, 3004
    • Alfred Health
  • Perth, Australia, 6009
    • Sir Charles Gairdner Hospital
  • Saint Leonards, Australia, 2065
    • Royal North Shore Hospital
  • Southport, Australia, 4215
    • Gold Coast University Hospital
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Hamilton, New Zealand, 3204
    • Waikato Hospital Hamilton
• Thailand
  • Bangkok, Thailand
    • Siriraj Hospital
  • Songkhla, Thailand, 90110
    • Prince of Songkla University - Songklanagarind Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with degenerative, atherosclerotic thoracoabdominal aortic aneurysm who are scheduled for implantation of an E-nside TAAA Multibranch Stent Graft at their physician's discretion and who are eligible in accordance with the criteria listed below.

Description

Inclusion Criteria:

• Patient is between 18 and 85 years old
• Patient has a degenerative, atherosclerotic thoracoabdominal aortic aneurysm
• Patient has adequate iliac/femoral access compatible with an 8.5 mm OD delivery system
• Patient's aorta has no distinct angulation in the thoracovisceral segment of the aorta ranging from 40 mm proximal to the celiac trunk to 20 mm distal to the lowest renal artery
• All target branch vessels are suitable for antegrade cannulation
• Diameter of the landing zone in each branch vessel to be treated is ≥ 5 mm
• Length of landing zone in each branch vessel to be treated is ≥ 15 mm (preferably ≥ 20 mm)
• Patient must be available for the appropriate follow-up times for the duration of the study
• Patient has signed the informed consent before implantation of the E-nside Stent Graft

Exclusion Criteria:

• Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)
• Patient has systemic infection or suspected systemic infection
• Patient has an infectious aneurysm
• Patient has an inflammatory aneurysm
• Patient has a ruptured aneurysm
• Patient has a traumatic aneurysm
• Patient has a symptomatic aneurysm
• Patient has an aortic dissection
• Patient has a congenital degenerative collagen disease or connective tissue disorder
• Diameter of ostium of branch vessel to be treated < 4 mm
• Patient has thrombocytopenia (platelet count < 150000/μl)
• Patient has an eGFR < 30 ml/min/1.73m2 before the intervention
• Patient has untreated hyperthyroidism
• Patient has a malignancy (progressive, stable or partial remission)
• Patient had a myocardial infarction or cerebrovascular accident < 3 months ago
• Patient is planned to be treated with a chimney in the left subclavian artery
• Patient has had a previous surgical repair of descending thoracic aorta
• Patient will be treated or had been treated with a Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) or Anaconda (Vascutek) stent graft
• Patient is enrolled or plans to be enrolled in another clinical study
• Patient is pregnant or breastfeeding or planning to become pregnant during the course of the study.
• Patient has a life expectancy of less than 3 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	3-6 months, 12 months
Rupture	Rate of patients with aneurysm rupture	through study completion, an average of 12 months
Major adverse events	Rate of patients with major adverse events	Prior to Discharge, 30 days, 3-6 months, 12 months
Number of interventions	Rate of interventions in peri-operative periods	Intra-Op
Time E-nside delivery system remained in access vessels	Rate of time intervals the E-nside delivery system remained in the access vessels in relation to the number of branches treated with pre-cannulation	through study completion, an average of 12 months
Reinterventions	Rate of reinterventions	30 days, 3-6, 12 months
Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin	Rate of patients with type Ia, Ib, Ic endoleak (at 12 months follow-up)	12 months
Intercomponent separation	Rate of patients with intercomponent separation at the proximal or distal end of the E-nside stent graft > 10 mm	Prior to Discharge, 30 days, 3-6 months, 12 months
Loss of device integrity	Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break)	Prior to Discharge, 30 days, 3-6 months, 12 months
Kinking of E-nside Stent Graft or bridging stents	Rate of patients with E-nside stent graft or bridging stent kinking	Prior to Discharge, 30 days, 3-6 months, 12 months
Primary and secondary patency (overall and separately for each type of branch)	Rate of primary/secondary patency of bridging stents Rate of primary/secondary patency of the bridging stent of the celiac trunk Rate of primary/secondary patency of the bridging stent of the superior mesenteric artery Rate of primary/secondary patency of the bridging stent of the right renal artery Rate of primary/secondary patency of the bridging stent of the left renal artery Rate of primary/secondary patency of branch vessels treated	Prior to Discharge, 30 days, 3-6 months, 12 months
Stent graft infection	Rate of patients with stent graft infection	through study completion, an average of 12 months
Primary and secondary technical success	Rate of patients with primary/secondary technical success	24 hours
Primary and secondary clinical success	Rate of patients with primary/secondary clinical success	12 months
Stable, decreasing or increasing aneurysm size	Rate of patients with stable, decreasing or increasing aneurysm size	12 months
Removal or failure to implant the stent graft	Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft	through study completion, an average of 12 months

Collaborators and Investigators

• Sponsor: JOTEC GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): November 15, 2024
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: surgery; aneurysm; aortic; vascular; thoracoabdominal
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal; Aneurysm
• Other Study ID Numbers: INNER-B-APAC

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