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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05954793
Registration number
NCT05954793
Ethics application status
Date submitted
23/06/2023
Date registered
20/07/2023
Titles & IDs
Public title
A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)
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Scientific 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
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Secondary ID [1]
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INNER-B-APAC
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thoracoabdominal Aortic Aneurysm
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mortality
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Assessment method [1]
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Rate of all-cause mortality
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Timepoint [1]
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30 days
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Secondary outcome [1]
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Mortality
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Assessment method [1]
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Rate of all-cause mortality
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Timepoint [1]
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3-6 months, 12 months
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Secondary outcome [2]
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Rupture
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Assessment method [2]
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Rate of patients with aneurysm rupture
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Timepoint [2]
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through study completion, an average of 12 months
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Secondary outcome [3]
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Major adverse events
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Assessment method [3]
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Rate of patients with major adverse events
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Timepoint [3]
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Prior to Discharge, 30 days, 3-6 months, 12 months
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Secondary outcome [4]
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Number of interventions
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Assessment method [4]
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Rate of interventions in peri-operative periods
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Timepoint [4]
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Intra-Op
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Secondary outcome [5]
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Time E-nside delivery system remained in access vessels
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Assessment method [5]
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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
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Timepoint [5]
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through study completion, an average of 12 months
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Secondary outcome [6]
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Reinterventions
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Assessment method [6]
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Rate of reinterventions
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Timepoint [6]
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30 days, 3-6, 12 months
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Secondary outcome [7]
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Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin
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Assessment method [7]
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Rate of patients with type Ia, Ib, Ic endoleak (at 12 months follow-up)
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Intercomponent separation
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Assessment method [8]
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Rate of patients with intercomponent separation at the proximal or distal end of the E-nside stent graft \> 10 mm
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Timepoint [8]
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Prior to Discharge, 30 days, 3-6 months, 12 months
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Secondary outcome [9]
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Loss of device integrity
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Assessment method [9]
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Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break)
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Timepoint [9]
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Prior to Discharge, 30 days, 3-6 months, 12 months
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Secondary outcome [10]
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Kinking of E-nside Stent Graft or bridging stents
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Assessment method [10]
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Rate of patients with E-nside stent graft or bridging stent kinking
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Timepoint [10]
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Prior to Discharge, 30 days, 3-6 months, 12 months
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Secondary outcome [11]
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Primary and secondary patency (overall and separately for each type of branch)
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Assessment method [11]
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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
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Timepoint [11]
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Prior to Discharge, 30 days, 3-6 months, 12 months
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Secondary outcome [12]
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Stent graft infection
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Assessment method [12]
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Rate of patients with stent graft infection
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Timepoint [12]
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through study completion, an average of 12 months
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Secondary outcome [13]
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Primary and secondary technical success
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Assessment method [13]
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Rate of patients with primary/secondary technical success
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Timepoint [13]
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24 hours
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Secondary outcome [14]
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Primary and secondary clinical success
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Assessment method [14]
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Rate of patients with primary/secondary clinical success
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Timepoint [14]
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12 months
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Secondary outcome [15]
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Stable, decreasing or increasing aneurysm size
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Assessment method [15]
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Rate of patients with stable, decreasing or increasing aneurysm size
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Timepoint [15]
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12 months
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Secondary outcome [16]
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Removal or failure to implant the stent graft
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Assessment method [16]
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Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft
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Timepoint [16]
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through study completion, an average of 12 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2025
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment hospital [2]
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Sir Charles Gairdner Hospital - Perth
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Recruitment hospital [3]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [4]
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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6009 - Perth
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Recruitment postcode(s) [3]
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2065 - Saint Leonards
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Hamilton
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Country [3]
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Thailand
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State/province [3]
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Bangkok
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Country [4]
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Thailand
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State/province [4]
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Songkhla
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
JOTEC GmbH
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05954793
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Mihail Georgiev
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Address
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Country
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Phone
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+4915115397693
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05954793