Aortic Dissection Type BNCT05874206
CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
A study testing Cratos™ Stent Graft in people with Aortic Dissection Type B and Intramural Hematoma, run by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd at 1 site in Switzerland.
Trial summary
The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Dissection Type B, Intramural Hematoma, Penetrating Aortic Ulcer
- What is being tested?
- Cratos™ Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Mar 2024to Dec 2031
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2
- Age ≥18 years at time of informed consent signature
- Informed Consent Form (ICF) is signed by Subject or legal representative
- Must have appropriate proximal aortic landing zone, defined as:
- Landing zone inner diameters between 23-41 mm
- The length of landing zone ≥15mm
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- Landing without heavily calcified or heavily thrombosed
- Dissection Patients: Primary entry tear must be distal to LSA, and proximal extent of the proximal landing zone must not be dissected.
- For patients with prior replacement of the ascending aorta and/or aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.
- Must have appropriate LSA landing zone, defined as:
- Inner diameters of LSA 5-14 mm
- Minimum length of Left subclavian artery is 25 mm
- Target branch vessel landing zone must be in native aorta that cannot be severely tortuous , aneurysmal, dissected, heavily calcified, or heavily thrombosed.
- Must have appropriate distal aortic landing zone, defined as:
- Aortic inner diameters between 18-44 mm
- Landing zone cannot be heavily calcified, or heavily thrombosed.
- For isolated PAU, outer curvature length must be ≥ 2cm proximal to the celiac artery
- Landing zone in native aorta
Who cannot join
- Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- Previous endovascular repair of the ascending aorta
- Infected aorta, active systemic infection
- Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .
- Life expectancy <1 years
- Myocardial infarction within 6 weeks prior to treatment
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- Stroke within 6 weeks prior to treatment.
- Pregnant or breastfeeding female
- Patient has an active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection.
- Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome
- Participation in another drug or medical device study within one year of study enrolment
- Known history of drug abuse within one year of treatment
- Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
- Planned coverage of celiac artery
- Allergic to contrast agents, anaesthetics and delivery materials
- Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- Patient with a history of a hypercoagulability disorder and/or is currently in a hypercoagulability state
- Persistent refractory shock (systolic blood pressure <90 mm Hg)
- Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (ml/min/1.73 m2) or currently requiring dialysis
- Contraindications to antiplatelet drugs and anticoagulants
- Investigator judged that not suitable for interventional treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich
Alexander Zimmermann, +41 44 255 20 39, gefaesschirurgie@usz.ch
About this study
Official title: Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question[s] it aims to answer are:
- 30-day all-cause Mortality rate
- Composite of the following events from the time of enrolment through 12-month:
- Device Technical Success
- Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system
Read more
Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:
- Physical examination
- Modified Rankin scale
- Tarlov scoring scale
- CTA
- Being tested
- Cratos™ Stent Graft
- Medical subject headings
- Penetrating Atherosclerotic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cratos™ Stent GraftDevice
Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.
| Study group | Role | What they receive |
|---|---|---|
| TEVAR | Experimental | Thoracic Endovascular Repair (TEVAR) provides a minimally invasive treatment option for descending thoracic aorta (DTA) pathologies. Receives: Device: Cratos™ Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start8 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection Type BStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qmed Consulting A/S
- Responsible party
- Sponsor
- Investigators
- Alexander Zimmermann, Prof. Dr., Principal investigator, Universitätz Spital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874206
- Sponsor's protocol ID
- ENDO_E23-01
- Status last verified
- Sep 2024
- First submitted
- 5 May 2023
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
- ClinicalTrials.gov ID
- NCT05874206
- Acronym / sponsor ID
- ENDO_E23-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Qmed Consulting A/S
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 24 May 2023 (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 goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question[s] it aims to answer are:
- 30-day all-cause Mortality rate
- Composite of the following events from the time of enrolment through 12-month:
- Device Technical Success
- Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system
Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:
- Physical examination
- Modified Rankin scale
- Tarlov scoring scale
- CTA
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEVAR | Experimental | Device: Cratos™ Stent GraftThoracic Endovascular Repair (TEVAR) provides a minimally invasive treatment option for descending thoracic aorta (DTA) pathologies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2
- Age ≥18 years at time of informed consent signature
- Informed Consent Form (ICF) is signed by Subject or legal representative
- Must have appropriate proximal aortic landing zone, defined as:
- Must have appropriate LSA landing zone, defined as:
Key exclusion criteria (21 listed)
- Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- Previous endovascular repair of the ascending aorta
- Infected aorta, active systemic infection
- Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .
- Life expectancy <1 years
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 |
|---|---|---|
| Cratos™ Stent GraftCratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions. | Device | TEVAR |
Primary outcome
Mortality
Time frame: 30-day
All-cause mortality
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 26 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Alexander Zimmermann, Prof. Dr. principal investigator
Universitätz Spital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cratos™ Stent Graft in people with Aortic Dissection Type B and Intramural Hematoma, run by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd at 1 site in Switzerland.
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 18 inclusion and 21 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Jing Wang (3105283618, jing.wang@endovastec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30-day). 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 26 Feb 2025.