Registry in Patients With Thoracoabdominal Aneurysms | NCT03295682

Studies
Registry in Patients With Thoracoabdominal Aneurysms

NCT03295682

Sponsor

JOTEC GmbH

Status

Completed

Last Update Posted

Feb 17, 2026Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Thoracoabdominal Aneurysm

Interventions

Endovascular thoracoabdominal aneurysm repair

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2017Actual

Primary Completion Date

May 31, 2022Actual

Completion Date

Aug 30, 2024Actual

First Submitted Date

Sep 25, 2017

First Submission Date that Met QC Criteria

Sep 25, 2017

First Posted Date

Sep 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

36 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample