Actively Recruiting
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
Led by Ceric Sàrl · Updated on 2024-05-01
30
Participants Needed
4
Research Sites
201 weeks
Total Duration
On this page
Sponsors
C
Ceric Sàrl
Lead Sponsor
E
European Cardiovascular Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old
- Participants must understand and sign informed consent approved by the study sponsor
- Candidates for revascularization of the brachiocephalic trunk, left common carotid artery, and left subclavian artery
- Able to tolerate surgical revascularization of these vessels
- For thoracic aortic aneurysms or penetrating ulcers: fusiform aneurysm ≥ 5.5 cm or > 2 times normal diameter; or saccular aneurysm or penetrating ulcer ≥ 10 mm depth and 20 mm diameter or symptomatic
- Healthy, non-diseased aortic proximal seal zone of at least 20 mm
- No thrombus in the proximal neck
- Non-diseased aortic diameter between 25 mm and 42 mm, ascending aorta ≤ 40 mm
- Non-diseased left subclavian artery eligible for stent-grafting
- Sufficient landing zone within left subclavian artery to accommodate stent-graft without vessel occlusion
- Compatible brachial, iliac, or femoral artery morphology for vascular access
- Symptomatic patients needing semi-urgent repair and at high surgical risk who cannot wait 6-8 weeks for custom stent graft
- Affiliated with the social security system
- For Type B aortic dissection and residual dissection after Type A repair: degenerative aortic arch aneurysm or complicated Type B dissection or complicated residual dissection requiring coverage of left subclavian artery and proximal seal extension to zone 0
- Healthy, non-diseased aortic proximal and distal seal zones of at least 20 mm
- Maximum diameter of distal ascending aorta just above brachiocephalic trunk ≤ 40 mm
- Non-diseased aortic diameter between 28 mm and 42 mm, ascending aorta ≤ 40 mm
- No atheromatous lesions in arch and supra-aortic vessels
- Compatible access vessel morphology
- Symptomatic patients needing semi-urgent repair and at high surgical risk who cannot wait 6-8 weeks
- Affiliated with the social security system
You will not qualify if you...
- Aneurysmal, tortuous, or atherosclerotic left subclavian artery, left common carotid artery, or brachiocephalic trunk
- Ascending aorta diameter > 40 mm
- Thrombus in the proximal neck
- Emergent need for treatment of aortic pathology
- Prohibitive calcification, occlusive disease, or tortuosity at intended sealing sites
- Circumferential calcification in femoral or iliac arteries with diameter less than 9 mm unless surgical adjunct planned
- Aortic atheroma grade IV or V
- Previous endovascular repair of the ascending aorta
- Significant or circumferential aortic mural thrombus at proximal or distal attachment sites
- Pregnancy
- Known allergy or intolerance to device components
- Acute renal failure
- Body habitus preventing adequate aortic visualization
- Untreated coronary artery disease with unstable angina
- Connective tissue disease (e.g., Marfan's syndrome)
- Active systemic infection or mycotic aneurysm
- Current participation in another investigational drug or device trial interfering with this study
- Other medical, social, or psychological problems interfering with treatment or follow-up
- Life expectancy less than 2 years
- Need for treatment of infrarenal aneurysm at implantation
- Previous surgical or endovascular treatment of infrarenal aneurysm within 30 days
- History of bleeding disorders or refusal of blood transfusion
- Cerebral vascular accident within 3 months
- Myocardial infarction within 3 months
- Known hypersensitivity or contraindication to anticoagulants or contrast media not manageable by pre-treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
CH de Brest
Brest, France, 29200
Actively Recruiting
2
Hôpital Louis Pradel
Bron, France, 69677
Not Yet Recruiting
3
CHU de Montpellier
Montpellier, France, 34295
Actively Recruiting
4
CH d'Orléans
Orléans, France, 45100
Not Yet Recruiting
Research Team
L
Laure Morsiani, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here