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
152 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
Researchers are evaluating the safety and effectiveness of the Valiant Captivia physician fenestrated stent graft system in treating conditions affecting the aortic arch and descending thoracic aorta. This includes aneurysms, penetrating ulcers, Type B aortic dissections, and residual dissections after Type A repair. The study focuses on patients who are candidates for revascularisation of all three major supra-aortic vessels: the brachiocephalic trunk, left common carotid artery, and left subclavian artery. The study involves implanting the Valiant Captivia physician fenestrated stent graft device to repair these aortic conditions. It is a prospective, single-arm, non-randomised, multicenter clinical study. The stent graft is used for revascularisation of the three supra-aortic vessels in patients with specific aortic pathologies. Participants are treated with this device during the procedure and monitored through discharge and follow-up visits. Participants will be assessed during and immediately after the procedure, with clinical utility measures collected until hospital discharge. Safety and effectiveness outcomes are primarily measured at 30 days post-implantation. Additional follow-up includes monitoring for major adverse events and secondary procedures for up to three years. The study involves imaging and clinical assessments to evaluate the device performance, safety, and patient outcomes over time.
CONDITIONS
Brief 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...
- Subject is at least 18 years of age.
- Subject understands and has signed an informed consent approved by the sponsor.
- Subject is a candidate for revascularisation of the brachiocephalic trunk, left common carotid artery, and left subclavian artery.
- Subject can tolerate surgical revascularisation of these vessels.
- For thoracic aortic aneurysms or penetrating ulcers: has a fusiform aneurysm ≥5.5 cm or >2 times the normal aortic diameter; or has a saccular aneurysm or penetrating ulcer ≥10 mm in depth and 20 mm in diameter, or symptomatic.
- Has a 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 diameter ≤40 mm.
- Has a non-diseased left subclavian artery eligible for stent-grafting with sufficient landing zone.
- Suitable brachial, iliac, or femoral artery access vessel morphology compatible with the device.
- Symptomatic patient needing semi-urgent repair and at high surgical risk.
- Subject is affiliated with the social security system.
- For Type B aortic dissections and residual dissection after Type A repair: has degenerative aortic arch aneurysm or complicated dissection requiring coverage of the left subclavian artery and extension of proximal seal zone to zone 0.
- Healthy, non-diseased aortic proximal and distal seal zones of at least 20 mm.
- Maximum diameter of distal ascending aorta above brachiocephalic trunk ≤40 mm.
- No atheromatous lesions in arch and supra-aortic vessels.
- Suitable vascular access vessel morphology.
- Symptomatic and semi-urgent repair needed.
- Affiliated with 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 over 40 mm.
- Thrombus in the proximal neck.
- Emergent need for aortic pathology treatment.
- Prohibitive calcification, occlusive disease, or tortuosity at sealing sites.
- Circumferential calcification in common femoral or iliac arteries with diameter less than 9 mm unless surgical procedure planned.
- Aortic atheroma grade IV or V.
- Previous endovascular repair of ascending aorta or arch.
- Significant or circumferential aortic mural thrombus compromising device sealing.
- Pregnancy.
- Known allergy or intolerance to device components.
- Acute renal failure.
- Body habitus preventing adequate aorta visualization.
- Unstable coronary artery disease untreated.
- Connective tissue disease such as Marfan's syndrome.
- Active systemic infection or mycotic aneurysm.
- Participation in conflicting investigational drug or device trials.
- Medical, social, or psychological problems interfering with treatment or follow-up.
- Life expectancy less than 2 years.
- Need for infrarenal aneurysm treatment at implantation.
- Recent surgical or endovascular treatment of infrarenal aortic aneurysm within 30 days.
- History of bleeding disorders or refusal of blood transfusion.
- Recent cerebral vascular accident or myocardial infarction within 3 months.
- Hypersensitivity or contraindication to anticoagulants or contrast media not manageable by pretreatment.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive implantation of the Valiant Captivia physician fenestrated stent graft for treatment of aortic arch and descending thoracic aorta pathologies.
1 procedure visit (in-person)
Duration - Up to 30 days
Participants undergo immediate post-operative care following stent graft implantation.
Multiple visits during hospital stay up to discharge
Duration - Up to 3 years
Participants are monitored for safety and effectiveness outcomes after discharge, including assessment of adverse events and secondary procedures.
Regular follow-up visits over 3 years
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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