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

Vascular Aneurysm Clinical Trial

— INNER-B  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04383145
• Other study ID #: INNER-B
• Status: Recruiting
• Start date: July 15, 2020
• Est. completion date: February 28, 2030

Study information

• Verified date: February 2024
• Source: JOTEC GmbH
• Contact: Mihail Georgiev
• Phone: +49 151 15397693
• Email: mihail.georgiev[@]artivion.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 28, 2030
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Vascular Aneurysm

Intervention

Device:
• endovascular repair
Endovascular repair of thoracoabdominal aneurysm using stent grafts.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Rate of all-cause mortality	30-day
Secondary	Mortality	Rate of all-cause mortality in peri-operative periods (all related interventions)	24 hours
Secondary	Mortality	Rate of all-cause mortality	3-6, 12, 24, 36, 60 months
Secondary	Rupture	Rate of patients with aneurysm rupture	30-day, 3-6, 12, 24, 36, 60 months
Secondary	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
Secondary	Number of intervention(s)	Rate of interventions in peri-operative periods (all related interventions until index procedure)	perioperative
Secondary	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
Secondary	Reintervention	Rate of reintervention(s)	30 days, 3-6, 12, 24, 36, 60 months
Secondary	Endoleak Type Ia	Rate of patients with type Ia endoleak	12, 24, 36, 60 months
Secondary	Endoleak Type Ib	Rate of patients with type Ib endoleak	12, 24, 36, 60 months
Secondary	Endoleak Type Ic	Rate of patients with type Ic endoleak	12, 24, 36, 60 months
Secondary	Endoleak Type II	Rate of patients with type II endoleak	12, 24, 36, 60 months
Secondary	Endoleak Type III	Rate of patients with type III endoleak	12, 24, 36, 60 months
Secondary	Endoleak Type IV	Rate of patients with type IV endoleak	12, 24, 36, 60 months
Secondary	Endoleak of unknown origin	Rate of patients with endoleak of unknown origin	12, 24, 36, 60 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Kinking	Rate of patients with E-nside stent graft or bridging stent graft kinking	prior to discharge/30 days, 12, 24, 36, 60 months
Secondary	Primary patency	Rate of primary patency of bridging stents	prior to discharge/30 days, 12, 24, 36, 60 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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	Secondary patency	Rate of secondary patency of bridging stents	prior to discharge/30 days, 12, 24, 36, 60 months
Secondary	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	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	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	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
Secondary	Infection	Rate of patients with stent graft infection	30-day, 12, 24, 36, 60 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stable aneurysm size	Rate of patients with stable aneurysm size	12, 24, 36, 60 months
Secondary	Decreasing (< 5 mm) aneurysm size	Rate of patients with decreasing aneurysm size	12, 24, 36, 60 months
Secondary	Increasing (> 5 mm) aneurysm size	Rate of patients with increasing aneurysm size	12, 24, 36, 60 months
Secondary	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