Registry in Patients With Thoracoabdominal Aneurysms (CONNECT)

JOTEC

Status: Active, not recruiting

Conditions: Thoracoabdominal Aneurysm

Treatments: Device: Endovascular thoracoabdominal aneurysm repair

Study type: Observational

Funder types: Industry

Identifiers

NCT03295682

CONNECT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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