Registry in Patients With Thoracoabdominal Aneurysms

NCT ID: NCT03295682

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2025-03-31

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.

Detailed Description

In this study patients will be observed, who receive a multi-branch stent graft tailored to the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with a multi-branch stent graft produced by JOTEC GmbH. 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 36 months from the intervention for each patient. A risk based source data verification will be performed. CT angiograms will be evaluated by a CoreLab.

Conditions

Thoracoabdominal Aneurysm

Study Design

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

Interventions

Endovascular thoracoabdominal aneurysm repair

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Sponsors

JOTEC GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hubert Schelzig, Professor

Role: STUDY_DIRECTOR

Uniklinikum Düsseldorf

Locations

Uniklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

CONNECT

Identifier Type: -

Identifier Source: org_study_id