Registry in Patients With Thoracoabdominal Aneurysms (CONNECT)

January 25, 2024 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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
    • NRW
      • Düsseldorf, NRW, 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

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

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

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

JOTEC GmbH

Investigators

  • 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)

September 11, 2017

Primary Completion (Actual)

May 31, 2022

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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