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

JOTEC GmbH150 enrolled

Overview

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.

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

150

Conditions

Vascular Aneurysm

Interventions

endovascular repairDEVICE

Endovascular repair of thoracoabdominal aneurysm using stent grafts.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Heidelberg

Heidelberg, Germany

RECRUITING

Outcomes

Primary Outcomes

Mortality

Rate of all-cause mortality

Time frame: 30-day

Secondary Outcomes

Mortality

Rate of all-cause mortality in peri-operative periods (all related interventions)

Time frame: 24 hours

Mortality

Rate of all-cause mortality

Time frame: 3-6, 12, 24, 36, 60 months

Rupture

Rate of patients with aneurysm rupture

Time frame: 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)

Time frame: 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)

Time frame: 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

Central Contacts

Mihail Georgiev

CONTACT

+49 151 15397693 mihail.georgiev@artivion.com

Data from ClinicalTrials.gov

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Time frame: perioperative

Reintervention

Rate of reintervention(s)

Time frame: 30 days, 3-6, 12, 24, 36, 60 months

Endoleak Type Ia

Rate of patients with type Ia endoleak

Time frame: 12, 24, 36, 60 months

Endoleak Type Ib

Rate of patients with type Ib endoleak

Time frame: 12, 24, 36, 60 months

Endoleak Type Ic

Rate of patients with type Ic endoleak

Time frame: 12, 24, 36, 60 months

Endoleak Type II

Rate of patients with type II endoleak

Time frame: 12, 24, 36, 60 months

Endoleak Type III

Rate of patients with type III endoleak

Time frame: 12, 24, 36, 60 months

Endoleak Type IV

Rate of patients with type IV endoleak

Time frame: 12, 24, 36, 60 months

Endoleak of unknown origin

Rate of patients with endoleak of unknown origin

Time frame: 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