Clinical trial NCT04383145: A Study in Patients With Thoracoabdominal Aortic Aneurysm Treated With the E-nside TAAA Multibranch Stent Graft System
Official title: INNER-B - A 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: Vascular Aneurysm
Keywords: Thoracoabdominal
aorta
aneurysm
endovascular
repair
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 150
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: 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 inclusion / exclusion criteria.

Brief summary: The INNER-B post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a thoracoabdominal aneurysm when treated by the E-nside TAAA Multibranch Stent Graft System.

The secondary objective is to evaluate the safety and clinical performance of the device.

Detailed description: In this study patients will be observed, who receive an E-nside TAAA Multibranch Stent Graft System for the endovascular treatment 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.

The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent 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 enrolment
* Patient has untreated hyperthyroidism
* Patient has a malignancy (progressive, stable or partial remission) with less than one-year projected survival
* 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-day
Secondary outcomes:
measure: Mortality
timeFrame: 24 hours
measure: Mortality
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Rupture
timeFrame: 30-day, 3-6, 12, 24, 36, 60 months
measure: Major Adverse Events (MAE)
timeFrame: prior to discharge, 30 days, 3-6, 12, 24, 36, 60 months
measure: Number of intervention(s)
timeFrame: perioperative
measure: Delivery time
timeFrame: perioperative
measure: Reintervention
timeFrame: 30 days, 3-6, 12, 24, 36, 60 months
measure: Endoleak Type Ia
timeFrame: 12, 24, 36, 60 months
measure: Endoleak Type Ib
timeFrame: 12, 24, 36, 60 months
measure: Endoleak Type Ic
timeFrame: 12, 24, 36, 60 months
measure: Endoleak Type II
timeFrame: 12, 24, 36, 60 months
measure: Endoleak Type III
timeFrame: 12, 24, 36, 60 months
measure: Endoleak Type IV
timeFrame: 12, 24, 36, 60 months
measure: Endoleak of unknown origin
timeFrame: 12, 24, 36, 60 months
measure: Proximal intercomponent separation
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Distal intercomponent separation
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Integrity
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Kinking
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Primary patency
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Primary patency of bridging stent of the celiac trunk
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Primary patency of bridging stent of the superior mesenteric artery
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Primary patency of bridging stent of the right renal artery
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Primary patency of bridging stent of the left renal artery
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Secondary patency
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Secondary patency of the bridging stent of the celiac trunk
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Secondary patency of the bridging stent of the superior mesenteric artery
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Secondary patency of the bridging stent of the right renal artery
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Secondary patency of the bridging stent of the left renal artery
timeFrame: prior to discharge/30 days, 12, 24, 36, 60 months
measure: Infection
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Primary technical success
timeFrame: 24 hours
measure: Technical success
timeFrame: 24 hours
measure: Primary clinical success
timeFrame: 12, 24, 36, 60 months
measure: Clinical success
timeFrame: 12, 24, 36, 60 months
measure: Stable aneurysm size
timeFrame: 12, 24, 36, 60 months
measure: Decreasing (< 5 mm) aneurysm size
timeFrame: 12, 24, 36, 60 months
measure: Increasing (> 5 mm) aneurysm size
timeFrame: 12, 24, 36, 60 months
measure: Stent graft removal
timeFrame: 24 hours, prior to discharge/30 days, 12, 24, 36, 60 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Dittmar Böckler, Prof. Dr.
role: STUDY_DIRECTOR
References: