Dissection of Thoracic AortaCEDARNCT07668687
European Multi-Centre Post-Market Registry on Thoracic Endovascular Arch Repair Using Castor™ and Cratos™
An observational study of Dissection of Thoracic Aorta and Dissection of Thoracic Descending Aorta, run by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta, Aneurysm of Aorta, Thoracic
- What is being tested?
- Implantation with Castor™ stent graft and Implantation with Cratos™ stent graft
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Sep 2025to Dec 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: approximately 100 patients in Europe, competitive enrolment
Who may be able to join
- Implantation of a Castor™ or Cratos™ single branch endoprothesis with incorporation of the left subclavian artery
- Age >18 years
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
ASKLEPIOS Kliniken St. Georg
Hamburg, 20099
Prof. Dr. med., 004940181885 ext. 2492, t.koeppel@asklepios.com
Thomas A Koeppel, Prof. Dr. med.
- Recruiting
Universitätsklinikum Münster (UKM)
Münster, 48149
Jana Ebing, 00492518351717, vital@ukmuenster.de
Alexander Oberhuber, Dr. med. univ.
Switzerland2 sites, 2 recruiting
- Recruiting
Hôpital de Sion
Sion, 1951
Daniel Danzer, 0041276034124, daniel.danzer@hopitalvs.ch
Daniel Danzer
- Recruiting
Universitätsspital Zürich (USZ)
Zurich, CH-8091
Susanne Menz, 0041432530243, Susanne.Menz@usz.ch
Alexander Zimmermann, Prof. Dr. med.
About this study
Official title: European Multi-Centre Castor™ and Cratos™ Branched Endovascular Arch Repair Registry
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.
Read the detailed description
The CEDAR registry is a post-market clinical study with retrospective and prospective enrollment and retrospective and prospective data collection.
- Conditions
- Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta, Aneurysm of Aorta, Thoracic, Penetrating Aortic Ulcers (PAUs), Intramural Hematoma of the Thoracic Aorta, Ulcer-like Projection (ULP)
- Being tested
- Implantation with Castor™ stent graft, Implantation with Cratos™ stent graft
- Keywords
- Castor™ Branched Aortic Stent Graft System, Cratos™ Branched Aortic Stent Graft System, TEVAR, thoracic aortic aneurysm (TAA), Penetrating Aortic Ulcer (PAU), Aortic Intramural Haematoma (IMH), Ulcer-like projection (ULP), thoracic aortic dissection
- Medical subject headings
- Dissection, Thoracic Aorta, Aortic Aneurysm, Penetrating Atherosclerotic Ulcer, Aortic Aneurysm, Thoracic, Aortic Intramural Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation with Castor™ stent graftDevice
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 graftDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: patients treated with Castor™ | Arch involving aortic pathologies treated with the Castor™ stent graft system. Receives: Device: Implantation with Castor™ stent graft | |
| Cohort 2: patients treated with Cratos™ | Arch involving aortic pathologies treated with the Cratos™ stent graft system. Receives: Device: Implantation with Cratos™ stent graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
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™.
Measured: 30 days
Technical success rate
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.
Measured: 24 hours
Secondary outcomes (9)
Clinical success rate 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.
Measured: at 30 days, 6 months and at 1 - 5 years
Rate of Endoleak
Measured: at 30 days, 6 months, and at 1 - 5 years
Branch occlusion rate
Measured: at 30 days, 6 months, and 1-5 year
Rate of perioperative retrograde type A aortic dissections
Measured: 30 days, 6 months, and at 1 - 5 years
Rate of reintervention
Measured: at 30 days, 6 months, and at 1-5 years
Combined endpoint major adverse events
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.
Measured: at 30-days, 6 months and 1 year
Incidence rate of spinal cord ischemia for the duration of the study
Measured: at 30 days, 6 months, and at 1 - 5 years
Stroke rate
Measured: at 30 days, 6 months, and at 1 - 5 years
All-cause mortality
Measured: at 30 days, 6 months, and at 1 - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start12 Sep 2025
- Primary completionOct 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissection of Thoracic AortaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Wang, Study director, Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668687
- Sponsor's protocol ID
- PMCF-2025-01
- Acronym
- CEDAR
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multi-Centre Castor™ and Cratos™ Branched Endovascular Arch Repair Registry
- ClinicalTrials.gov ID
- NCT07668687
- Acronym / sponsor ID
- CEDAR / PMCF-2025-01
- Conditions
- Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta, Aneurysm of Aorta, Thoracic, Penetrating Aortic Ulcers (PAUs), Intramural Hematoma of the Thoracic Aorta, Ulcer-like Projection (ULP)
- Keywords
- Castor™ Branched Aortic Stent Graft System, Cratos™ Branched Aortic Stent Graft System, TEVAR, thoracic aortic aneurysm (TAA), Penetrating Aortic Ulcer (PAU), Aortic Intramural Haematoma (IMH), Ulcer-like projection (ULP), thoracic aortic dissection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CEDAR registry is a post-market clinical study with retrospective and prospective enrollment and retrospective and prospective data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: patients treated with Castor™ | – | Device: Implantation with Castor™ stent graftArch involving aortic pathologies treated with the Castor™ stent graft system. |
| Cohort 2: patients treated with Cratos™ | – | Device: Implantation with Cratos™ stent graftArch involving aortic pathologies treated with the Cratos™ stent graft system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- approximately 100 patients in Europe, competitive enrolment
Key inclusion criteria (2 listed)
- Implantation of a Castor™ or Cratos™ single branch endoprothesis with incorporation of the left subclavian artery
- Age >18 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation with Castor™ stent graftTreatment 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. | Device | Cohort 1: patients treated with Castor™ |
| Implantation with Cratos™ stent graftTreatment 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. | Device | Cohort 2: patients treated with Cratos™ |
Primary outcome
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™.
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.
9 secondary outcomes
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
Rate of Endoleak
Time frame: at 30 days, 6 months, and at 1 - 5 years
Branch occlusion rate
Time frame: at 30 days, 6 months, and 1-5 year
Rate of perioperative retrograde type A aortic dissections
Time frame: 30 days, 6 months, and at 1 - 5 years
Rate of reintervention
Time frame: at 30 days, 6 months, and at 1-5 years
Combined endpoint major adverse events
Time frame: at 30-days, 6 months and 1 year
Incidence rate of spinal cord ischemia for the duration of the study
Time frame: at 30 days, 6 months, and at 1 - 5 years
Stroke rate
Time frame: at 30 days, 6 months, and at 1 - 5 years
All-cause mortality
Time frame: at 30 days, 6 months, and at 1 - 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Wang study director
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dissection of Thoracic Aorta and Dissection of Thoracic Descending Aorta, run by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie Shen, MD MSc (00441235750800, maggie.shen@endovastec-lm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.