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

NCT04383145 | Active Not Recruiting

• 1 other identifier: INNER-B
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Aneurysm

Keywords

Thoracoabdominal; aorta; aneurysm; endovascular; repair

Outcome Measures

Primary Outcomes (1)

• Mortality

  Rate of all-cause mortality

  30-day

Secondary Outcomes (37)

• Mortality

  24 hours

• Mortality

  3-6, 12, 24, 36, 60 months

• Rupture

  30-day, 3-6, 12, 24, 36, 60 months

• Major Adverse Events (MAE)

  prior to discharge, 30 days, 3-6, 12, 24, 36, 60 months

• Number of intervention(s)

  perioperative

Interventions

endovascular repair DEVICE

Endovascular repair of thoracoabdominal aneurysm using stent grafts.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (1)

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Dittmar Böckler, Prof. Dr.

  University Hospital Heidelberg

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 12, 2020
• Study Start: July 15, 2020
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 28, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

DE (1)