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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
Date last updated
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)
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
Secondary ID [1] 0 0
INNER-B-APAC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracoabdominal Aortic Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
3-6 months, 12 months
Secondary outcome [2] 0 0
Rupture
Timepoint [2] 0 0
through study completion, an average of 12 months
Secondary outcome [3] 0 0
Major adverse events
Timepoint [3] 0 0
Prior to Discharge, 30 days, 3-6 months, 12 months
Secondary outcome [4] 0 0
Number of interventions
Timepoint [4] 0 0
Intra-Op
Secondary outcome [5] 0 0
Time E-nside delivery system remained in access vessels
Timepoint [5] 0 0
through study completion, an average of 12 months
Secondary outcome [6] 0 0
Reinterventions
Timepoint [6] 0 0
30 days, 3-6, 12 months
Secondary outcome [7] 0 0
Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Intercomponent separation
Timepoint [8] 0 0
Prior to Discharge, 30 days, 3-6 months, 12 months
Secondary outcome [9] 0 0
Loss of device integrity
Timepoint [9] 0 0
Prior to Discharge, 30 days, 3-6 months, 12 months
Secondary outcome [10] 0 0
Kinking of E-nside Stent Graft or bridging stents
Timepoint [10] 0 0
Prior to Discharge, 30 days, 3-6 months, 12 months
Secondary outcome [11] 0 0
Primary and secondary patency (overall and separately for each type of branch)
Timepoint [11] 0 0
Prior to Discharge, 30 days, 3-6 months, 12 months
Secondary outcome [12] 0 0
Stent graft infection
Timepoint [12] 0 0
through study completion, an average of 12 months
Secondary outcome [13] 0 0
Primary and secondary technical success
Timepoint [13] 0 0
24 hours
Secondary outcome [14] 0 0
Primary and secondary clinical success
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
Stable, decreasing or increasing aneurysm size
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
Removal or failure to implant the stent graft
Timepoint [16] 0 0
through study completion, an average of 12 months

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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [4] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton
Country [3] 0 0
Thailand
State/province [3] 0 0
Bangkok
Country [4] 0 0
Thailand
State/province [4] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
JOTEC GmbH
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05954793
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mihail Georgiev
Address 0 0
Country 0 0
Phone 0 0
+4915115397693
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05954793