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

Type B Aortic Dissection Clinical Trial

— EVERGREEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479305
• Other study ID #: EVERGREEN
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: Ceric Sàrl
• Contact: Laure Morsiani, PhD
• Phone: +33.1.76.73.92.36
• Email: contact[@]cerc-europe.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2027
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Aortic
• Aortic Aneurysm
• Aortic Dissection
• Type B Aortic Dissection

Intervention

Device:
• The Valiant Captivia Stent Graft
Aortic arch/Descending aorta Repair

Locations

Country	Name	City	State
France	CH de Brest	Brest
France	Hôpital Louis Pradel	Bron
France	CHU de Montpellier	Montpellier
France	CH d'Orléans	Orléans

Sponsors (2)

Lead Sponsor	Collaborator
Ceric Sàrl	European Cardiovascular Research Center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Primary	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	30 days
Secondary	Intra/periprocedural through Discharge Clinical Utility Measures 1	Mean duration (min) of the procedure.	0 to 30 days
Secondary	Intra/periprocedural through Discharge Clinical Utility Measures 2	• Mean time (min) to implant	0 to 30 days
Secondary	Intra/periprocedural through Discharge Clinical Utility Measures 3	Proportion of subjects who underwent general anaesthesia.	0 to 30 days
Secondary	Intra/periprocedural through Discharge Clinical Utility Measures 4	Mean volume (cc) of estimated blood loss.	0 to 30 days
Secondary	Intra/periprocedural through Discharge Clinical Utility Measures 5	Proportion of subjects requiring blood transfusion	0 to 30 days
Secondary	Intra/periprocedural through Discharge Clinical Utility Measures 6	Mean length of time (days) of overall hospital stays	0 to 30 days
Secondary	Intra/periprocedural through Discharge Clinical Utility Measures 7	Mean length of time (hours) in the intensive care unit.	0 to 30 days
Secondary	Major adverse event	All-Cause Mortality; Myocardial Infarction; Paraplegia/Paraparesis; Renal Failure; Stroke/TIA; Left Arm/Hand Ischemia	Up to 3 years
Secondary	Secondary endovascular procedures	repeating procedures	Up to 3 years
Secondary	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)	Up to 3 years
Secondary	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	Up to 3 years
Secondary	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	0 to 30 days