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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Contact Information
Primary
Mihail Georgiev
mihail.georgiev@artivion.com
+49 151 15397693
Time Frame
Start Date: 2020-07-15
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 150
Related Therapeutic Areas
Sponsors
Leads: JOTEC GmbH

This content was sourced from clinicaltrials.gov