Registry in Patients With Thoracoabdominal Aneurysms (CONNECT)

February 12, 2026 updated by: JOTEC GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Uniklinikum Düsseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)
Time Frame: 12 months follow-up
Decreasing size: >/= 5mm Increasing size: </= 5mm compared to first post-operative CT angiogram
12 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rate of all cause mortality
Time Frame: intra-op, post-op until 36 months follow-up
intra-op, post-op until 36 months follow-up
Rate of patients with aneurysm rupture
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of interventions in peri-operative periods (all related interventions until index procedure)
Time Frame: intra-op
intra-op
Rate of reinterventions
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with endoleaks type Ia, Ib, II, III, IV, V and of unknown origin
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with multi-branch stent graft migration
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with loss of device integrity
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with primary / secondary patency of branch vessels
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with stent graft infection
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with primary / secondary technical success
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with primary / secondary clinical success
Time Frame: post-op until 36 months follow-up
post-op until 36 months follow-up
Rate of patients with removal or failure to implant the multi-branch stent graft
Time Frame: intra-op, post-op until 36 months follow-up
intra-op, post-op until 36 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JOTEC GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hubert Schelzig, Professor, Uniklinikum Düsseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CONNECT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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