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Completed

NCT Number: NCT03295682

Registry in Patients With Thoracoabdominal Aneurysms

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.

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Key information

Conditions

Thoracoabdominal Aneurysm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of all cause mortality

    Time frame: intra-op, post-op until 36 months follow-up

  2. Rate of patients with aneurysm rupture

    Time frame: post-op until 36 months follow-up

  3. Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)

    Time frame: post-op until 36 months follow-up

  4. Rate of interventions in peri-operative periods (all related interventions until index procedure)

    Time frame: intra-op

  5. Rate of reinterventions

    Time frame: post-op until 36 months follow-up

  6. 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

  7. Rate of patients with multi-branch stent graft migration

    Time frame: post-op until 36 months follow-up

  8. Rate of patients with loss of device integrity

    Time frame: post-op until 36 months follow-up

  9. Rate of patients with primary / secondary patency of branch vessels

    Time frame: post-op until 36 months follow-up

  10. Rate of patients with stent graft infection

    Time frame: post-op until 36 months follow-up

  11. Rate of patients with primary / secondary technical success

    Time frame: post-op until 36 months follow-up

  12. Rate of patients with primary / secondary clinical success

    Time frame: post-op until 36 months follow-up

  13. 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

Sponsors and collaborators

Lead sponsor

JOTEC GmbH

Industry

Registry information

Official study title

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

Acronym: CONNECT

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
Sep 28, 2017
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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