Status:
UNKNOWN
Safety, Efficacy and Cost Analysis of the Conformable Thoracic Stent Graft With ACTIVE CONTROL
Lead Sponsor:
Endovascular Foundation
Collaborating Sponsors:
W.L.Gore & Associates
Bocconi University
Conditions:
Thoracic Aorta
Thoracic Aorta Aneurysm
Eligibility:
All Genders
18-90 years
Brief Summary
Study Design This is a prospective, multicenter, non-randomized clinical study in patients presenting thoracic aortic pathologies. Following a baseline assessment, the implantation procedure will be ...
Detailed Description
Brief Summary: Study Design This is a prospective, multicenter, non-randomized clinical study in patients presenting thoracic aortic pathologies. Following a baseline assessment, the implantation pro...
Eligibility Criteria
Inclusion
- Male / female
- Age between 18 and 90 years of age
- Patient diagnosed with thoracic aorta pathology (TAA, TBAD, BTAI, PAU, IMH) suitable for TEVAR with a C-TAG Active Control stent-graft; diagnosis must be confirmed by contrast computed tomography angiography (CTA) or magnetic resonance imaging (MRI) within 3 months of the planned implant procedure.
- Proximal and distal aortic necks suitable for stent-graft placement (i.e., inner diameter ranging between 16 and 42 mm)
- Proximal and distal landing zones suitable for the stent-graft
- Adequate vascular access for insertion of the delivery system
- Written informed consent upon enrolment
Exclusion
- Aneurysm/lesion location not accessible to the delivery system and stent placement
- Arterial access size insufficient for delivery system entrance or impossibility to perform a surgical access conduit
- Treatment of lesion that would require a delivery system with usable length greater than 90 cm
- Excessive arterial disease precluding delivery system entrance or passage
- Systemic infection
- Arterial tortuosity not allowing passage of the delivery system
- Arterial or aneurysm/lesion size incompatible with stent graft
- Mycotic aneurysm/lesions
- Massive thrombus
- Bleeding diathesis
- Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator
- Untreatable allergy or history of allergic reaction to radiographic contrast medium
- Untreatable allergy or history of allergic reaction to anticoagulants
- Hypersensitivity to any of the components of the C-TAG device
- Participation in an investigational clinical study involving a new chemical entity or medical device within 3 months or 1 year, respectively, prior to the planned procedure
- Patient not willing to give consent for transmission of personal "pseudonymised" data
- For females: pregnancy or lactation
- Women of childbearing potential (not postmenopausal or surgically sterile) not willing to use an effective method of contraception during the study. Effective methods are hormonal contraceptives (e.g., oral, implanted, or injected), intrauterine device (IUDs), and sexual abstinence.
- Patient committed to an institution by virtue of an order issued either by the courts or by an authority
- Patient who is unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04452240
Start Date
July 1 2020
End Date
December 1 2024
Last Update
September 21 2021
Active Locations (3)
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1
Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
2
Spedali Civili di Brescia
Brescia, Italy
3
Hospital Clinic of Barcelona
Barcelona, Spain, 08036