Clinical trial NCT05954793: A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracoabdominal Aortic Aneurysm
Keywords: aneurysm
thoracoabdominal
aortic
vascular
surgery
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients with degenerative, atherosclerotic thoracoabdominal aortic aneurysm who are scheduled for implantation of an E-nside TAAA Multibranch Stent Graft at their physician's discretion and who are eligible in accordance with the criteria listed below.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 3-6 months, 12 months
measure: Rupture
timeFrame: through study completion, an average of 12 months
measure: Major adverse events
timeFrame: Prior to Discharge, 30 days, 3-6 months, 12 months
measure: Number of interventions
timeFrame: Intra-Op
measure: Time E-nside delivery system remained in access vessels
timeFrame: through study completion, an average of 12 months
measure: Reinterventions
timeFrame: 30 days, 3-6, 12 months
measure: Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin
timeFrame: 12 months
measure: Intercomponent separation
timeFrame: Prior to Discharge, 30 days, 3-6 months, 12 months
measure: Loss of device integrity
timeFrame: Prior to Discharge, 30 days, 3-6 months, 12 months
measure: Kinking of E-nside Stent Graft or bridging stents
timeFrame: Prior to Discharge, 30 days, 3-6 months, 12 months
measure: Primary and secondary patency (overall and separately for each type of branch)
timeFrame: Prior to Discharge, 30 days, 3-6 months, 12 months
measure: Stent graft infection
timeFrame: through study completion, an average of 12 months
measure: Primary and secondary technical success
timeFrame: 24 hours
measure: Primary and secondary clinical success
timeFrame: 12 months
measure: Stable, decreasing or increasing aneurysm size
timeFrame: 12 months
measure: Removal or failure to implant the stent graft
timeFrame: through study completion, an average of 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Health
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital Hamilton
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Songkhla
country: Thailand
facility: Prince of Songkla University - Songklanagarind Hospital
Study officials:
References: