A Study in Patients With Thoracoabdominal Aortic Aneurysm Treated With the E-nside TAAA Multibranch Stent Graft System (INNER-B)

INNER-B - A Post-market Clinical Follow-up Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Aneurysm
• Intervention / Treatment: Device: endovascular repair

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Mihail Georgiev; Phone Number: +49 151 15397693; Email: mihail.georgiev@artivion.com

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitätsklinikum Heidelberg
    • Contact: Dittmar Böckler, Prof. Dr.; Phone Number: +49 6221 56-6249; Email: dittmar.boeckler@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	3-6, 12, 24, 36, 60 months
Mortality	Rate of all-cause mortality in peri-operative periods (all related interventions)	24 hours
Rupture	Rate of patients with aneurysm rupture	30-day, 3-6, 12, 24, 36, 60 months
Major Adverse Events (MAE)	Rate of patients with major adverse events (aneurysm related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke, visceral ischemia (bowel ischemia with surgery or submission to ICU or bowel necrosis with surgery or submission to ICU), new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, new permanent paraplegia, new permanent paraparesis, lower limb ischemia (increase in Rutherford classification) (product-related, procedure-related, aneurysm-related)	prior to discharge, 30 days, 3-6, 12, 24, 36, 60 months
Number of intervention(s)	Rate of interventions in peri-operative periods (all related interventions until index procedure)	perioperative
Delivery time	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	perioperative
Reintervention	Rate of reintervention(s)	30 days, 3-6, 12, 24, 36, 60 months
Endoleak Type Ia	Rate of patients with type Ia endoleak	12, 24, 36, 60 months
Endoleak Type Ib	Rate of patients with type Ib endoleak	12, 24, 36, 60 months
Endoleak Type Ic	Rate of patients with type Ic endoleak	12, 24, 36, 60 months
Endoleak Type II	Rate of patients with type II endoleak	12, 24, 36, 60 months
Endoleak Type III	Rate of patients with type III endoleak	12, 24, 36, 60 months
Endoleak Type IV	Rate of patients with type IV endoleak	12, 24, 36, 60 months
Endoleak of unknown origin	Rate of patients with endoleak of unknown origin	12, 24, 36, 60 months
Proximal intercomponent separation	Rate of patients with intercomponent separation at the proximal end of the E-nside stent graft > 10 mm	prior to discharge/30 days, 12, 24, 36, 60 months
Distal intercomponent separation	Rate of patients with intercomponent separation at the distal end of the E-nside stent graft > 10 mm	prior to discharge/30 days, 12, 24, 36, 60 months
Integrity	Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break)	prior to discharge/30 days, 12, 24, 36, 60 months
Kinking	Rate of patients with E-nside stent graft or bridging stent graft kinking	prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency	Rate of primary patency of bridging stents	prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of bridging stent of the celiac trunk	Rate of primary patency of the bridging stent of the celiac trunk	prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of bridging stent of the superior mesenteric artery	Rate of primary patency of the bridging stent of the superior mesenteric artery	prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of bridging stent of the right renal artery	Rate of primary patency of the bridging stent of the right renal artery	prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of bridging stent of the left renal artery	Rate of primary patency of the bridging stent of the left renal artery	prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency	Rate of secondary patency of bridging stents	prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency of the bridging stent of the celiac trunk	Rate of secondary patency of the bridging stent of the celiac trunk	prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency of the bridging stent of the superior mesenteric artery	Rate of secondary patency of the bridging stent of the superior mesenteric artery	prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency of the bridging stent of the right renal artery	Rate of secondary patency of the bridging stent of the right renal artery	prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency of the bridging stent of the left renal artery	Rate of secondary patency of the bridging stent of the left renal artery	prior to discharge/30 days, 12, 24, 36, 60 months
Infection	Rate of patients with stent graft infection	30-day, 12, 24, 36, 60 months
Primary technical success	Rate of patients with primary technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated within 24 h after the index procedure. Successful introduction and deployment of the E-nside TAAA Multibranch Stent Graft in the absence of: Surgical conversion Mortality Reintervention Unplanned branch vessel occlusion (post-operative occlusion) Including: Secure proximal and distal fixation Patent treated branch vessels	24 hours
Technical success	Rate of patients with technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure.	24 hours
Primary clinical success	Rate of patients with primary clinical success. Primary clinical success is reported on an intent-to-treat basis and is reached if the following criteria are fulfilled at the time of follow-up starting at 12 months follow-up: Successful deployment of the endovascular devices at the intended location in the absence of: Death as result of aneurysm-related treatment Conversion to open repair Reintervention after index procedure Occlusion of treated branch vessels Type I or III endoleak Increasing aneurysm size Aneurysm rupture	12, 24, 36, 60 months
Clinical success	Rate of patients with clinical success. Clinical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure.	12, 24, 36, 60 months
Stable aneurysm size	Rate of patients with stable aneurysm size	12, 24, 36, 60 months
Decreasing (< 5 mm) aneurysm size	Rate of patients with decreasing aneurysm size	12, 24, 36, 60 months
Increasing (> 5 mm) aneurysm size	Rate of patients with increasing aneurysm size	12, 24, 36, 60 months
Stent graft removal	Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft	24 hours, prior to discharge/30 days, 12, 24, 36, 60 months

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Investigators: Study Director: Dittmar Böckler, Prof. Dr., University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: aneurysm; endovascular; Thoracoabdominal; repair; aorta
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm, Abdominal; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal
• Other Study ID Numbers: INNER-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No