Registry in Patients With Thoracoabdominal Aneurysms

NCT03295682 | Completed

• 1 other identifier: CONNECT
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

In this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. The objective of this study is to evaluate clinical and technical success as well as safety and feasibility of the multi-branch stent graft Systems used in endovascular treatment of thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices. Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm size at 12 months follow-up.

Conditions

Thoracoabdominal Aneurysm

Outcome Measures

Primary Outcomes (1)

• Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)

  Decreasing size: \>/= 5mm Increasing size: \</= 5mm compared to first post-operative CT angiogram

  12 months follow-up

Secondary Outcomes (13)

• Rate of all cause mortality

  intra-op, post-op until 36 months follow-up

• Rate of patients with aneurysm rupture

  post-op until 36 months follow-up

• Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)

  post-op until 36 months follow-up

• Rate of interventions in peri-operative periods (all related interventions until index procedure)

  intra-op

• Rate of reinterventions

  post-op until 36 months follow-up

Interventions

Endovascular thoracoabdominal aneurysm repair DEVICE

Endovascular treatment of patients with thoracoabdominal aneurysm using a multibranch stent graft tailored to the patient´s anatomy in combination with peripheral covered stents to bridge the visceral arteries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total number of 40 male and female patients with asymptomatic thoracoabdominal aortic aneurysm, treated with a multi-branch stent graft system.

You may qualify if:

• Age ≥ 18 years
• Patients must have a thoracoabdominal aneurysm type Crawford type I, II, III, IV, or V
• Patients must have a suitable proximal landing area
• Patients must have a suitable distal landing area in the abdominal aorta or the iliac arteries
• Patients must have suitable access vessels
• Patients must be available for the appropriate follow-up times for the duration of the study
• Patients have signed the informed consent before intervention

You may not qualify if:

• Patients with infectious aneurysm
• Patients with inflammatory aneurysm
• Patients with ruptured or symptomatic aneurysm
• Patients with traumatic aneurysm
• Patients with aortic dissection
• Patients who have a congenital degenerative collagen disease or connective tissue disorder
• Patients with thrombocytopenia
• Patients with an eGFR \< 45ml/min/1.73m2 before the intervention
• Patients with untreated hyperthyroidism
• Patients with malignancy needing chemotherapy or radiation
• Patients that will be treated or are treated with iliac branch devices
• Patients pre-treated with Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) stent grafts
• Patients who are enrolled in another clinical study
• Patients with life expectancy of less than 36 months

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (1)

Uniklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Study Officials

• Hubert Schelzig, Professor

  Uniklinikum Düsseldorf

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: September 11, 2017
• Primary Completion: May 31, 2022
• Study Completion: August 30, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

DE (1)