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

Thoracoabdominal Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954793
• Other study ID #: INNER-B-APAC
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: JOTEC GmbH
• Contact: Mihail Georgiev
• Phone: +4915115397693
• Email: mihail.georgiev[@]artivion.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• Thoracoabdominal Aortic Aneurysm

Locations

Country	Name	City	State
Australia	Alfred Health	Melbourne
Australia	Sir Charles Gairdner Hospital	Perth
Australia	Royal North Shore Hospital	Saint Leonards
Australia	Gold Coast University Hospital	Southport
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato Hospital Hamilton	Hamilton
Thailand	Siriraj Hospital	Bangkok
Thailand	Prince of Songkla University - Songklanagarind Hospital	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Countries where clinical trial is conducted

Australia,  New Zealand,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Rate of all-cause mortality	30 days
Secondary	Mortality	Rate of all-cause mortality	3-6 months, 12 months
Secondary	Rupture	Rate of patients with aneurysm rupture	through study completion, an average of 12 months
Secondary	Major adverse events	Rate of patients with major adverse events	Prior to Discharge, 30 days, 3-6 months, 12 months
Secondary	Number of interventions	Rate of interventions in peri-operative periods	Intra-Op
Secondary	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
Secondary	Reinterventions	Rate of reinterventions	30 days, 3-6, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stent graft infection	Rate of patients with stent graft infection	through study completion, an average of 12 months
Secondary	Primary and secondary technical success	Rate of patients with primary/secondary technical success	24 hours
Secondary	Primary and secondary clinical success	Rate of patients with primary/secondary clinical success	12 months
Secondary	Stable, decreasing or increasing aneurysm size	Rate of patients with stable, decreasing or increasing aneurysm size	12 months
Secondary	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