Penetrating Ulcer of AortaEVERGREENNCT05479305
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
A study testing The Valiant Captivia Stent Graft in people with Penetrating Ulcer of Aorta and Aneurysm Aortic, run by Ceric Sàrl at 4 sites in France.
Trial summary
The study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft. Clinical utility measures throughout the procedure and until discharge will be assessed Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Penetrating Ulcer of Aorta, Aneurysm Aortic, Type B Aortic Dissection
- What is being tested?
- The Valiant Captivia Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Nov 2023to Oct 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TAA/PAU (Thoracic Aortic Aneurysms and Penetrating Ulcers):
- Subject is at least 18 years of age.
- Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
- Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.
- Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.
- Subject has a TAA/PAU which is:
Show all 28Show fewer
- a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR
- a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm in diameter, or symptomatic)
- Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm
- Subject has no thrombus in the proximal neck
- Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter of the ascending aorta is ≤ 40 mm
- Subject has a non-diseased LSA which is eligible for stent-grafting
- Subject has sufficient landing zone within the LSA to accommodate the stent-graft without occlusion of any significant vessels
- Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories.
- Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft
- Subject is affiliated with the social security system
- TBAD(Type B Dissections) and Residual dissection after Type A repair:
- Subject is at least 18 years of age.
- Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
- a) Subject has a degenerative aortic arch aneurysm which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And/or b) Subject has a complicated TBAD (acute, subacute or chronic) which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And/or c) Subject has a complicated residual dissection after replacement of the ascending aorta for type A aortic dissection which will require coverage of the LSA and extension of the proximal seal zone to zone 0
- Subject has a healthy, non-diseased (without thrombus) aortic proximal seal zone of at least 20 mm
- Subject has a healthy, non-diseased (without thrombus) aortic distal seal zone of at least 20 mm
- Subject has a maximum diameter of the distal ascending aorta just above the BT of 40 mm
- Subject has a non-diseased aortic diameter between 28 mm to 42 mm and the ascending aorta ≤ 40 m
- Subject has a no atheromatous lesions int the arch and the BT, LCCA and LSA
- Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories
- Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft
- Subject is affiliated with the social security system
Who cannot join
- (Thoracic Aortic Aneurysms and Penetrating Ulcers, TAA/PAU):
- Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
- Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
- Subject has an aneurysmal, tortuous, or atherosclerotic BT.
- Subject has an ascending aorta diameter > 40 mm
- Subject has thrombus in the proximal neck
Show all 55Show fewer
- Subject has an emergent need of treatment of the aortic pathology
- Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites
- Subject has circumferential calcification in the common femoral or external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
- Subject has an aortic atheroma classified as grade IV or grade V.
- Subject has had previous endovascular repair of the ascending
- Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise sealing of the device.
- Subject is pregnant
- Subject has a known allergy or intolerance to the device components.
- Subject is in acute renal failure
- Subject has a body habitus which prevents adequate visualisation of the aorta.
- Subject has coronary artery disease with unstable angina and who has not received treatment.
- Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
- Subject has active systemic infection and/or a mycotic aneurysm.
- Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observations of this study.
- Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
- Subject has a life expectancy of less than 2 years year.
- Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
- Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm <30 days of implantation of investigational device.
- Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- Subject has had a cerebral vascular accident (CVA) within 3 months.
- Subject has had a myocardial infarction (MI) within 3 months.
- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
- (Type B Dissections, TBAD and residual dissection after Type A repair):
- Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
- Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
- Subject has an aneurysmal, tortuous, or atherosclerotic BT.
- Subject has a dissected BT and or LCCA
- Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites.
- Subject has circumferential calcification in the common femoral artery, external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
- Subject has an aortic atheroma classified as grade IV or grade V.
- Subject has had previous endovascular repair of the ascending, arch
- Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal sealing sites that would compromise seal of the device
- Subject is pregnant
- Subject has a known allergy or intolerance to the device components
- Subject is in acute renal failure
- Subject has a body habitus which prevents adequate visualisation of the aorta.
- Subject has coronary artery disease with unstable angina and who has not received treatment.
- Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
- Subject has active systemic infection and/or a mycotic aneurysm.
- Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observationsof this study
- Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
- Subject has a life expectancy of less than 2 years.
- Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
- Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm <30 days of implantation of investigational device.
- Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- Subject has had a cerebral vascular accident (CVA) within 3 months.
- Subject has had a myocardial infarction (MI) within 3 months.
- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
- -
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CH de Brest
Brest, 29200
Bahaa Nasr
Bahaa Nasr
- Not yet recruiting
Hôpital Louis Pradel
Bron, 69677
Antoine Millon, Pr
Antoine Millon
- Recruiting
CHU de Montpellier
Montpellier, 34295
Ludovic Canaud, Professor
Sonia Soltani
- Not yet recruiting
CH d'Orléans
Orléans, 45100
Vivent Ziza
Vicent Ziza
About this study
The study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft.
Clinical utility measures throughout the procedure and until discharge will be assessed
Read the detailed description
Prospective, single-arm, non-randomised, multicenter, investigator initiated clinical study evaluating subjects implanted with The Valiant Captivia physician fenestrated stent graft for the treatment of aneurysms/penetrating ulcers, Type B aortic dissections or residual dissection after Type A repair, of the aortic arch and the descending thoracic aorta which are candidates for revascularisation of all three supra-aortic vessels (BT (brachiocephalic trunk) , LCCA (left Common Carotid artery), LSA (Left Subclavian Artery)
- Conditions
- Penetrating Ulcer of Aorta, Aneurysm Aortic, Type B Aortic Dissection, Residual Dissection After Type A Repair
- Being tested
- The Valiant Captivia Stent Graft
- Keywords
- aortic arch, descending thoracic aorta, valiant captivia stent graft
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Valiant Captivia Stent GraftDevice
Aortic arch/Descending aorta Repair
| Study group | Role | What they receive |
|---|---|---|
| Intervention/Treatment | Experimental | The Valiant Captivia physician fenestrated stent graft for the treatment of aneurysms/penetrating ulcers, Type B aortic dissections or residual dissection after Type A repair, of the aortic arch and the descending thoracic aorta which are candidates for revascularisation of all three supra-aortic vessels (BT, LCCA, LSA) Receives: Device: The Valiant Captivia Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoints:
Within one month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of:
- Aorta-Related Mortality
- Stroke/TIA (Transient Ischemic Attack)
- Paraplegia/paraparesis
- Left Arm/Hand Ischemia
Measured: 30 days
Primary Effectiveness Endpoints:
The primary effectiveness endpoint is treatment success (defined below) and will be captured within the initial reporting period of 1 month from the index procedure.
Treatment success defined as technical success comprising the following:
- the successful delivery and deployment of the stent graft (The Valiant Captivia physician fenestrated Stent Graft) at the planned location
- no unintentional coverage of supra-aortic vessels, assessed intra-operatively,
- the removal of the delivery system
- successful exclusion of the aortic lesion while maintaining patency of the LSA stent-graft as well as LCCA and BT at the 30-day visit
Measured: 30 days
Secondary outcomes (12)
Intra/periprocedural through Discharge Clinical Utility Measures 1
Mean duration (min) of the procedure.
Measured: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 2
- Mean time (min) to implant
Measured: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 3
Proportion of subjects who underwent general anaesthesia.
Measured: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 4
Mean volume (cc) of estimated blood loss.
Measured: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 5
Proportion of subjects requiring blood transfusion
Measured: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 6
Mean length of time (days) of overall hospital stays
Measured: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 7
Mean length of time (hours) in the intensive care unit.
Measured: 0 to 30 days
Major adverse event
All-Cause Mortality
- Myocardial Infarction
- Paraplegia/Paraparesis
- Renal Failure
- Stroke/TIA
- Left Arm/Hand Ischemia
Measured: Up to 3 years
Secondary endovascular procedures
repeating procedures
Measured: Up to 3 years
Secondary endovascular procedures for primary device failures
(including Type I/III endoleaks, aneurysm expansion, aneurysm/aortic rupture, and supra-aortic vessels including LSA stent-graft occlusion)
Measured: Up to 3 years
Other
- Rupture
- Endoleaks
- Maximum aneurysm diameter changes from baseline*
- Exclusion of aneurysm
- Exclusion of penetrating aortic ulcer (PAU)
- Stent graft patency
- Stent graft integrity
- Conversion to surgical repair
- Surgical revascularisation of the LSA, LCCA, BT
- Paraparesis
- Adverse events including serious adverse events and device, procedure, and/or disease-related adverse events
Measured: Up to 3 years
For TBAD, these additional observations will be evaluated
Coverage of primary entry tear (exclusion of false lumen)
- Extension of dissection (proximally or distally) with or without complications
- Continuing or new false lumen (FL) perfusion
- Aortic remodeling post-procedure
Measured: 0 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start21 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating Ulcer of AortaStudies of the same condition, open and under way.
- More trials run by Ceric SàrlThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479305
- Sponsor's protocol ID
- EVERGREEN
- Acronym
- EVERGREEN
- Status last verified
- Apr 2024
- First submitted
- 25 Jul 2022
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
- ClinicalTrials.gov ID
- NCT05479305
- Acronym / sponsor ID
- EVERGREEN / EVERGREEN
- Conditions
- Penetrating Ulcer of Aorta, Aneurysm Aortic, Type B Aortic Dissection, Residual Dissection After Type A Repair
- Keywords
- aortic arch, descending thoracic aorta, valiant captivia stent graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Jul 2022 (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 study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft.
Clinical utility measures throughout the procedure and until discharge will be assessed
Detailed description
Prospective, single-arm, non-randomised, multicenter, investigator initiated clinical study evaluating subjects implanted with The Valiant Captivia physician fenestrated stent graft for the treatment of aneurysms/penetrating ulcers, Type B aortic dissections or residual dissection after Type A repair, of the aortic arch and the descending thoracic aorta which are candidates for revascularisation of all three supra-aortic vessels (BT (brachiocephalic trunk) , LCCA (left Common Carotid artery), LSA (Left Subclavian Artery)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention/Treatment | Experimental | Device: The Valiant Captivia Stent GraftThe Valiant Captivia physician fenestrated stent graft for the treatment of aneurysms/penetrating ulcers, Type B aortic dissections or residual dissection after Type A repair, of the aortic arch and the descending thoracic aorta which are candidates for revascularisation of all three supra-aortic vessels (BT, LCCA, LSA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subject is at least 18 years of age.
- Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
- Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.
- Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.
- Subject has a TAA/PAU which is:
Key exclusion criteria (55 listed)
- Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
- Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
- Subject has an aneurysmal, tortuous, or atherosclerotic BT.
- Subject has an ascending aorta diameter > 40 mm
- Subject has thrombus in the proximal neck
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 |
|---|---|---|
| The Valiant Captivia Stent GraftAortic arch/Descending aorta Repair | Device | Intervention/Treatment |
Primary outcome
Primary Safety Endpoints:
Time frame: 30 days
Within one month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta-Related Mortality * Stroke/TIA (Transient Ischemic Attack) * Paraplegia/paraparesis * Left Arm/Hand Ischemia
Primary Effectiveness Endpoints:
Time frame: 30 days
The primary effectiveness endpoint is treatment success (defined below) and will be captured within the initial reporting period of 1 month from the index procedure. Treatment success defined as technical success comprising the following: * the successful delivery and deployment of the stent graft (The Valiant Captivia physician fenestrated Stent Graft) at the planned location * no unintentional coverage of supra-aortic vessels, assessed intra-operatively, * the removal of the delivery system * successful exclusion of the aortic lesion while maintaining patency of the LSA stent-graft as well as LCCA and BT at the 30-day visit
12 secondary outcomes
Intra/periprocedural through Discharge Clinical Utility Measures 1
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 2
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 3
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 4
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 5
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 6
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 7
Time frame: 0 to 30 days
Major adverse event
Time frame: Up to 3 years
Secondary endovascular procedures
Time frame: Up to 3 years
Secondary endovascular procedures for primary device failures
Time frame: Up to 3 years
Other
Time frame: Up to 3 years
For TBAD, these additional observations will be evaluated
Time frame: 0 to 30 days
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 1 May 2024.
- Individual participant dataSharing planned: No
Related trials for Penetrating Ulcer of Aorta
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RecruitingObservational study
European Multi-Centre Post-Market Registry on Thoracic Endovascular Arch Repair Using Castor™ and Cratos™
Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta
Active, not recruiting
Quick Yielding Modified Short-Distance Fenestration Technique for the Treatment of Complex Aortic Arch Diseases: a Multicenter Single-Arm Objective Performance Criteria Trial(QYM-Tech Study)
Thoracic Aortic Dissection, Thoracic Aortic Aneurysm (true Aneurysm)
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Valiant Captivia Stent Graft in people with Penetrating Ulcer of Aorta and Aneurysm Aortic, run by Ceric Sàrl at 4 sites in France.
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 28 inclusion and 55 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 1 May 2024. 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 France. 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 Laure Morsiani, PhD (+33.1.76.73.92.36, contact@cerc-europe.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoints: (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 1 May 2024.