Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies

Last updated: April 30, 2024
Sponsor: Ceric Sàrl
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Heart Disease

Cardiovascular Disease

Treatment

The Valiant Captivia Stent Graft

Clinical Study ID

NCT05479305
EVERGREEN
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 forthis 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 ofthe non-aneurysmal thoracic aorta; AND/OR
  • a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm indiameter, or symptomatic)
  1. Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm
  2. Subject has no thrombus in the proximal neck
  3. Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter ofthe ascending aorta is ≤ 40 mm
  4. Subject has a non-diseased LSA which is eligible for stent-grafting
  5. Subject has sufficient landing zone within the LSA to accommodate the stent-graftwithout occlusion of any significant vessels
  6. Brachial, iliac or femoral artery access vessel morphology (diameter, calcification,tortuosity) that is compatible with vascular access techniques, the device, oraccessories.
  7. Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk andcannot wait for 6-8 weeks for a custom-made stent graft
  8. Subject is affiliated with the social security system Inclusion criteria: TBAD(Type B Dissections) and Residual dissection after Type A repair:
  9. Subject is at least 18 years of age.
  10. Subject understands and has signed an Informed Consent approved by the Sponsor forthis study.
  11. a) Subject has a degenerative aortic arch aneurysm which will require coverage of theLSA and extension of the proximal seal zone to zone 0 And/or b) Subject has acomplicated TBAD (acute, subacute or chronic) which will require coverage of the LSAand extension of the proximal seal zone to zone 0 And/or c) Subject has a complicatedresidual dissection after replacement of the ascending aorta for type A aorticdissection which will require coverage of the LSA and extension of the proximal sealzone to zone 0
  12. Subject has a healthy, non-diseased (without thrombus) aortic proximal seal zone of atleast 20 mm
  13. Subject has a healthy, non-diseased (without thrombus) aortic distal seal zone of atleast 20 mm
  14. Subject has a maximum diameter of the distal ascending aorta just above the BT of 40mm
  15. Subject has a non-diseased aortic diameter between 28 mm to 42 mm and the ascendingaorta ≤ 40 m
  16. Subject has a no atheromatous lesions int the arch and the BT, LCCA and LSA
  17. Brachial, iliac or femoral artery access vessel morphology (diameter, calcification,tortuosity) that is compatible with vascular access techniques, the device, oraccessories
  18. Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk andcannot wait for 6-8 weeks for a custom-made stent graft
  19. Subject is affiliated with the social security system

Exclusion

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 intendedsealing sites
  8. Subject has circumferential calcification in the common femoral or external iliacartery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mmat any point proximal to or at the access vessel site unless a surgical adjunctiveprocedure 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 theproximal 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 receivedtreatment.
  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 trialthat would interfere with the observations of this study.
  20. Subject has other medical, social, or psychological problems that, in the opinion ofthe 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 aorticaneurysm <30 days of implantation of investigational device.
  24. Subject has a history of bleeding diathesis, coagulopathy, or refuses bloodtransfusion.
  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 contrastmedia, 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 intendedsealing sites. 6. Subject has circumferential calcification in the common femoral artery, external iliacartery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mmat any point proximal to or at the access vessel site unless a surgical adjunctiveprocedure 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 theproximal 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 receivedtreatment. 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 trialthat would interfere with the observationsof this study 18. Subject has other medical, social, or psychological problems that, in the opinion ofthe 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 aorticaneurysm <30 days of implantation of investigational device. 22. Subject has a history of bleeding diathesis, coagulopathy, or refuses bloodtransfusion. 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 contrastmedia, which is not amenable to pre-treatment.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: The Valiant Captivia Stent Graft
Phase:
Study Start date:
November 21, 2023
Estimated Completion Date:
October 31, 2027

Study 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)

Connect with a study center

  • CH de Brest

    Brest, 29200
    France

    Active - Recruiting

  • Hôpital Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier, 34295
    France

    Active - Recruiting

  • CH d'Orléans

    Orléans, 45100
    France

    Site Not Available

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