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

NCT05479305 | Recruiting

• 1 other identifier: EVERGREEN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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

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

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (12)

• Intra/periprocedural through Discharge Clinical Utility Measures 1

  0 to 30 days

• Intra/periprocedural through Discharge Clinical Utility Measures 2

  0 to 30 days

• Intra/periprocedural through Discharge Clinical Utility Measures 3

  0 to 30 days

• Intra/periprocedural through Discharge Clinical Utility Measures 4

  0 to 30 days

• Intra/periprocedural through Discharge Clinical Utility Measures 5

  0 to 30 days

Study Arms (1)

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)

Device: The Valiant Captivia Stent Graft

Interventions

The Valiant Captivia Stent Graft DEVICE

Aortic arch/Descending aorta Repair

Intervention/Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• (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
• 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

Sponsors & Collaborators

• Ceric Sàrl: lead
• European Cardiovascular Research Center: collaborator

Study Sites (4)

CH de Brest

Brest, 29200, France

RECRUITING

Hôpital Louis Pradel

Bron, 69677, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

CH d'Orléans

Orléans, 45100, France

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Laure Morsiani, PhD

CONTACT

+33.1.76.73.92.36; contact@cerc-europe.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 29, 2022
• Study Start: November 21, 2023
• Primary Completion: November 1, 2024
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)