Registry in Patients With Thoracoabdominal Aneurysms

Thoracoabdominal Aneurysm Clinical Trial

— CONNECT  

Official title:

Registry in Patients With Thoracoabdominal Aneurysms Treated With Multi-branch Stent Grafts Tailored to Their Individual Anatomies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03295682
• Other study ID #: CONNECT
• Status: Active, not recruiting
• Start date: September 11, 2017
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: JOTEC GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: March 31, 2025
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Thoracoabdominal Aneurysm

Intervention

Device:
• 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

Locations

Country	Name	City	State
Germany	Uniklinikum Düsseldorf	Düsseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)	Decreasing size: >/= 5mm Increasing size:	12 months follow-up
Secondary	Rate of all cause mortality		intra-op, post-op until 36 months follow-up
Secondary	Rate of patients with aneurysm rupture		post-op until 36 months follow-up
Secondary	Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)		post-op until 36 months follow-up
Secondary	Rate of interventions in peri-operative periods (all related interventions until index procedure)		intra-op
Secondary	Rate of reinterventions		post-op until 36 months follow-up
Secondary	Rate of patients with endoleaks type Ia, Ib, II, III, IV, V and of unknown origin		post-op until 36 months follow-up
Secondary	Rate of patients with multi-branch stent graft migration		post-op until 36 months follow-up
Secondary	Rate of patients with loss of device integrity		post-op until 36 months follow-up
Secondary	Rate of patients with primary / secondary patency of branch vessels		post-op until 36 months follow-up
Secondary	Rate of patients with stent graft infection		post-op until 36 months follow-up
Secondary	Rate of patients with primary / secondary technical success		post-op until 36 months follow-up
Secondary	Rate of patients with primary / secondary clinical success		post-op until 36 months follow-up
Secondary	Rate of patients with removal or failure to implant the multi-branch stent graft		intra-op, post-op until 36 months follow-up