Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/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
mihail.georgiev@artivion.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05954793