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

NCT ID: NCT05954793

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-01-31

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.

Conditions

Thoracoabdominal Aortic Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JOTEC GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alfred Health

Melbourne, , Australia

Site Status: NOT_YET_RECRUITING

Sir Charles Gairdner Hospital

Perth, , Australia

Site Status: NOT_YET_RECRUITING

Royal North Shore Hospital

Saint Leonards, , Australia

Site Status: NOT_YET_RECRUITING

Gold Coast University Hospital

Southport, , Australia

Site Status: NOT_YET_RECRUITING

Auckland City Hospital

Auckland, , New Zealand

Site Status: RECRUITING

Waikato Hospital Hamilton

Hamilton, , New Zealand

Site Status: RECRUITING

Siriraj Hospital

Bangkok, , Thailand

Site Status: RECRUITING

Prince of Songkla University - Songklanagarind Hospital

Songkhla, , Thailand

Site Status: RECRUITING

Countries

Australia; New Zealand; Thailand

Central Contacts

Mihail Georgiev

Role: CONTACT

mihail.georgiev@artivion.com

+4915115397693

Facility Contacts

Thodur Vasudevan, Dr.

Role: primary

Shirley Jansen, Prof.

Role: primary

Vikram Puttaswamy, Dr.

Role: primary

Venu Bhamidi, Dr.

Role: primary

Andrew Holden, Prof.

Role: primary

AndrewH@adhb.govt.nz

Manar Khashram, Dr.

Role: primary

Kiattisak Hongku, Dr.

Role: primary

Dhanakom Premprabha, Dr.

Role: primary

Other Identifiers

INNER-B-APAC

Identifier Type: -

Identifier Source: org_study_id