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

Sponsor

JOTEC GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05954793

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

Mortality [30 days]
Rate of all-cause mortality

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Alfred Health	Melbourne	Australia	3004
2	Sir Charles Gairdner Hospital	Perth	Australia	6009
3	Royal North Shore Hospital	Saint Leonards	Australia	2065
4	Gold Coast University Hospital	Southport	Australia	4215
5	Auckland City Hospital	Auckland	New Zealand	1023
6	Waikato Hospital Hamilton	Hamilton	New Zealand	3204
7	Siriraj Hospital	Bangkok	Thailand
8	Prince of Songkla University - Songklanagarind Hospital	Songkhla	Thailand	90110