Aortic Aneurysm Clinical Trial
— RE-GENERATIONOfficial title:
RE-GENERATION: An EU Clinical Study to Evaluate the Safety and Performance of the Relay Pro and Relay Non Bare Stent (NBS) Pro Stent-graft Devices in Patients With Thoracic Aortic Pathologies
Verified date | June 2017 |
Source | Bolton Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the study is to evaluate the safety and performance of Relay Pro and Relay
NBS Pro devices in humans having thoracic aortic pathologies.
Clinical results will be used to apply for the CE certification.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 30, 2016 |
Est. primary completion date | April 14, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patient diagnosed with thoracic aorta pathology (aneurysm, pseudoaneurysm, dissection, penetrating ulcer or intramural hematoma) suitable for TEVAR with a Relay Pro or Relay NBS Pro 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., diameter ranging between 18 and 42 mm) - Proximal and distal landing zones suitable for the stent-graft - Adequate vascular access for insertion of the delivery system, i.e., femoral or iliac arteries a minimum 6 mm in diameter to accommodate the 19 to 22-Fr outer-diameter delivery system and no excessive disease precluding delivery system entry/passage or iliac arteries that could be extended via an access conduit. - Written informed consent provided by the subject him/herself (not a representative) upon enrollment Exclusion Criteria: Patients who meet one or more of the following criteria are not eligible: - 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 - Has congenital connective tissue disease rendering the aneurysm/lesion untreatable - Mycotic aneurysm/lesions - Aortic inner diameter that cannot accommodate the expanded Inner Secondary Sheath outer diameter of approximately 10mm - Native 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 polyester or nitinol or any of the components of the Relay device - Patient underwent prior thoracic aortic repair (endovascular or surgical) - 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 theinvestigator should not participate in the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bolton Medical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from aneurysm or dissection-related mortality | All deaths due to the treated pathology, including aneurysm rupture, complications of TEVAR leading to new aortic pathology (e.g., retrograde dissection leading to fatal cardiac tamponade). | 30 days or less | |
Primary | Delivery and deployment success evaluation | Success will be based on the Delivery system evaluation, overall rate of vascular access complications Rate of access failures Rate of deployment system difficulties will be analyzed descriptively. |
30 days or less | |
Secondary | Major device-related adverse events (MAE) | MAEs include: Endoleak (types I, Ill and IV) Stent migration (>10 mm)2 Lumen occlusion Aorta rupture Conversion to open repair |
30 days after the procedure |
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