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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05954793
Other study ID # INNER-B-APAC
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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