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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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

⁃ 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

Locations
Other Locations
France
CH de Brest
RECRUITING
Brest
Hôpital Louis Pradel
NOT_YET_RECRUITING
Bron
CHU de Montpellier
RECRUITING
Montpellier
CH d'Orléans
NOT_YET_RECRUITING
Orléans
Contact Information
Primary
Laure Morsiani, PhD
contact@cerc-europe.org
+33.1.76.73.92.36
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2027-10
Participants
Target number of participants: 30
Treatments
Experimental: Intervention/Treatment
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)
Sponsors
Leads: Ceric Sàrl
Collaborators: European Cardiovascular Research Center

This content was sourced from clinicaltrials.gov