Clinical trial NCT05479305: Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
Official title: Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2022-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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)

Eligibility criteria: Inclusion Criteria:

TAA/PAU (Thoracic Aortic Aneurysms and Penetrating Ulcers):

1. Subject is at least 18 years of age.
2. Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
3. Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.
4. Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.
5. Subject has a TAA/PAU which is:

   * 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)
6. Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm
7. Subject has no thrombus in the proximal neck
8. Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter of the ascending aorta is ≤ 40 mm
9. Subject has a non-diseased LSA which is eligible for stent-grafting
10. Subject has sufficient landing zone within the LSA to accommodate the stent-graft without occlusion of any significant vessels
11. Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories.
12. 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
13. Subject is affiliated with the social security system

Inclusion criteria:

TBAD(Type B Dissections) and Residual dissection after Type A repair:

1. Subject is at least 18 years of age.
2. Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
3. 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
4. Subject has a healthy, non-diseased (without thrombus) aortic proximal seal zone of at least 20 mm
5. Subject has a healthy, non-diseased (without thrombus) aortic distal seal zone of at least 20 mm
6. Subject has a maximum diameter of the distal ascending aorta just above the BT of 40 mm
7. Subject has a non-diseased aortic diameter between 28 mm to 42 mm and the ascending aorta ≤ 40 m
8. Subject has a no atheromatous lesions int the arch and the BT, LCCA and LSA
9. Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories
10. 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
11. Subject is affiliated with the social security system

Exclusion Criteria:

(Thoracic Aortic Aneurysms and Penetrating Ulcers, TAA/PAU):

1. Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
2. Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
3. Subject has an aneurysmal, tortuous, or atherosclerotic BT.
4. Subject has an ascending aorta diameter \> 40 mm
5. Subject has thrombus in the proximal neck
6. Subject has an emergent need of treatment of the aortic pathology
7. Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites
8. 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.
9. Subject has an aortic atheroma classified as grade IV or grade V.
10. Subject has had previous endovascular repair of the ascending
11. Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise sealing of the device.
12. Subject is pregnant
13. Subject has a known allergy or intolerance to the device components.
14. Subject is in acute renal failure
15. Subject has a body habitus which prevents adequate visualisation of the aorta.
16. Subject has coronary artery disease with unstable angina and who has not received treatment.
17. Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
18. Subject has active systemic infection and/or a mycotic aneurysm.
19. Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observations of this study.
20. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
21. Subject has a life expectancy of less than 2 years year.
22. Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
23. Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm \<30 days of implantation of investigational device.
24. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
25. Subject has had a cerebral vascular accident (CVA) within 3 months.
26. Subject has had a myocardial infarction (MI) within 3 months.
27. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

Exclusion criteria:

(Type B Dissections, TBAD and residual dissection after Type A repair):

1. Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
2. Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
3. Subject has an aneurysmal, tortuous, or atherosclerotic BT.
4. Subject has a dissected BT and or LCCA
5. Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites.
6. 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.
7. Subject has an aortic atheroma classified as grade IV or grade V.
8. Subject has had previous endovascular repair of the ascending, arch
9. Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal sealing sites that would compromise seal of the device
10. Subject is pregnant
11. Subject has a known allergy or intolerance to the device components
12. Subject is in acute renal failure
13. Subject has a body habitus which prevents adequate visualisation of the aorta.
14. Subject has coronary artery disease with unstable angina and who has not received treatment.
15. Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
16. Subject has active systemic infection and/or a mycotic aneurysm.
17. Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observationsof this study
18. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
19. Subject has a life expectancy of less than 2 years.
20. Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
21. Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm \<30 days of implantation of investigational device.
22. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
23. Subject has had a cerebral vascular accident (CVA) within 3 months.
24. Subject has had a myocardial infarction (MI) within 3 months.
25. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

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Primary outcomes:
measure: Primary Safety Endpoints:
timeFrame: 30 days
measure: Primary Effectiveness Endpoints:
timeFrame: 30 days
Secondary outcomes:
measure: Intra/periprocedural through Discharge Clinical Utility Measures 1
timeFrame: 0 to 30 days
measure: Intra/periprocedural through Discharge Clinical Utility Measures 2
timeFrame: 0 to 30 days
measure: Intra/periprocedural through Discharge Clinical Utility Measures 3
timeFrame: 0 to 30 days
measure: Intra/periprocedural through Discharge Clinical Utility Measures 4
timeFrame: 0 to 30 days
measure: Intra/periprocedural through Discharge Clinical Utility Measures 5
timeFrame: 0 to 30 days
measure: Intra/periprocedural through Discharge Clinical Utility Measures 6
timeFrame: 0 to 30 days
measure: Intra/periprocedural through Discharge Clinical Utility Measures 7
timeFrame: 0 to 30 days
measure: Major adverse event
timeFrame: Up to 3 years
measure: Secondary endovascular procedures
timeFrame: Up to 3 years
measure: Secondary endovascular procedures for primary device failures
timeFrame: Up to 3 years
measure: Other
timeFrame: Up to 3 years
measure: For TBAD, these additional observations will be evaluated
timeFrame: 0 to 30 days
Other outcomes:
Locations:
city: Brest
country: France
facility: CH de Brest
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Montpellier
country: France
facility: CHU de Montpellier
city: Orléans
country: France
facility: CH d'Orléans
Study officials:
References: