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NCT Number: NCT07668687

European Multi-Centre Post-Market Registry on Thoracic Endovascular Arch Repair Using Castor™ and Cratos™

The Castor™ and Cratos™ Branched Aortic Stent Graft Systems are medical devices designed for the minimally invasive endovascular treatment of thoracic aortic pathologies in the descending aorta. The goal of this multi-centre retrospective and prospective observational registry study is to capture the short-, medium- to long-term safety and performance data of how Castor™ and Cratos™ stent-grafts work in real-world settings (everyday medical practice). The aim is to study approximately 100 patients in European hospitals, with competitive enrollment.

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Key information

Conditions

Dissection of Thoracic Aorta Acute Aortic Syndrome Aneurysm Aneurysm of Aorta, Thoracic Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Dissection Aortic Intramural Hematoma Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Dissection of Thoracic Descending Aorta Dissection, Blood Vessel Dissection, Thoracic Aorta Hematoma Hemorrhage Intramural Hematoma of the Thoracic Aorta Pathologic Processes Pathological Conditions, Signs and Symptoms Penetrating Aortic Ulcers (PAUs) Penetrating Atherosclerotic Ulcer Ulcer-like Projection (ULP) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASKLEPIOS Kliniken St. Georg, Hamburg, Germany

Loading trial locations.

About this study

The CEDAR registry is a post-market clinical study with retrospective and prospective enrollment and retrospective and prospective data collection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Implantation of a Castor™ or Cratos™ single branch endoprothesis with incorporation of the left subclavian artery
  • Age >18 years

Exclusion criteria

  • Patients allergic to the materials of the device;
  • Patients with severe or potentially systemic infections that increase the chance of graft infection;
  • Minors and pregnant women;
  • Branch for other supra-aortic vessels than the LSA
  • Rejection of participation.

Treatment and study plan

Implantation with Castor™ stent graft

Device

Treatment of subjects diagnosed with thoracic aortic pathologies using the Castor™ Branched Aortic Stent-Graft and Delivery System. Follow up as per institutional standard of care.

Implantation with Cratos™ stent graft

Device

Treatment of subjects diagnosed with thoracic aortic pathologies using the Cratos™ Branched Aortic Stent-Graft and Delivery System. Follow up as per institutional standard of care.

Primary outcomes

  1. 30-day all-cause mortality

    Time frame: 30 days

    A measure of the total number of patients participating in the CEDAR study who die from any cause within 30 days of the implantation of the branched aortic stent graft - Castor™ or Cratos™.

  2. Technical success rate

    Time frame: 24 hours

    Technical Success is defined as successful access and deployment of the endograft, including implantation of the branch into the target vessel, with patency of the branch and no evidence of type I or type III endoleak on completion angiography or cone-beam computed tomography. Additional intra-operative measures to achieve this, such as ballooning or branch extension with additional stent grafts, are also considered as primary technical success.

Secondary outcomes

  1. Clinical success rate at 30 days, 6 months and at 1 - 5 years

    Time frame: at 30 days, 6 months and at 1 - 5 years

    This is defined as Technical Success plus the absence of aortic related death, aortic rupture, graft infection, sac expansion > 5mm, graft migration >10mm, persistent endoleaks type I and III requiring re-intervention, conversion to open surgery, permanent paraplegia, disabling stroke or permanent dialysis.

  2. Rate of Endoleak

    Time frame: at 30 days, 6 months, and at 1 - 5 years

  3. Branch occlusion rate

    Time frame: at 30 days, 6 months, and 1-5 year

  4. Rate of perioperative retrograde type A aortic dissections

    Time frame: 30 days, 6 months, and at 1 - 5 years

  5. Rate of reintervention

    Time frame: at 30 days, 6 months, and at 1-5 years

  6. Combined endpoint major adverse events

    Time frame: at 30-days, 6 months and 1 year

    all-cause mortality, myocardial infarction, respiratory failure with postoperative prolonged mechanical ventilation > 24h, renal function declining in a GFR > 50% reduction to perioperative, bowel ischemia requiring surgical resection, major stroke and permanent paraplegia.

  7. Incidence rate of spinal cord ischemia for the duration of the study

    Time frame: at 30 days, 6 months, and at 1 - 5 years

  8. Stroke rate

    Time frame: at 30 days, 6 months, and at 1 - 5 years

  9. All-cause mortality

    Time frame: at 30 days, 6 months, and at 1 - 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Woodman

CONTACT

[email protected]

00441235750800

Maggie Shen, MD MSc

CONTACT

[email protected]

00441235750800

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Industry

Registry information

Official study title

European Multi-Centre Castor™ and Cratos™ Branched Endovascular Arch Repair Registry

Acronym: CEDAR

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Jun 25, 2026
Registry last updated
Jun 25, 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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