Feasibility Clinical Study to Evaluate the Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thoracic Aortic Arch Disease
- Sponsor
- Endospan Ltd.
- Enrollment
- 18
- Locations
- 4
- Primary Endpoint
- Safety: Device related mortality at 30 days post implantation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
A multicenter, prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.
Detailed Description
The purpose of the study is to evaluate the safety and performance of the Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone 2). The Nexus™ Aortic Arch Stent Graft System is indicated for the endovascular treatment of thoracic aortic pathologies involving the aortic arch (such as aneurisms and dissections). The Nexus™ is intended to exclude the lesion from the blood circulation in patients diagnosed with thoracic aortic pathology and who have appropriate anatomy to accommodate the Nexus™ system in an endovascular procedure. The primary objectives of the study are to evaluate the safety and performance of the Nexus™ Aortic Arch Aneurysm Stent Graft System.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female age ≥
- •Any Thoracic Aorta pathology requiring landing in the Aortic Arch (zone 0, zone 1, zone2), e.g. aneurysm, dissection, false/Pseudo aneurysm.
- •In patient with a thoracic aneurysm: dilatation of the aortic arch larger than 5.5cm in diameter, or symptomatic aneurysm of the aortic arch, or aortic diameter growth rate \> 5mm per 6 months
- •Patient is considered an appropriate candidate for an elective surgery, as evaluated by Physical Status Classification System I, II or III (American Society of Anesthesiologists).
- •Femoral artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20-22Fr delivery catheter.
- •Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA, MRA.
- •Access vessel (femoral/iliac) diameter \> 7 mm
- •Ascending Aorta landing zone length \> 30 mm
- •Brachial/Axial Artery diameter \> 3 mm
- •Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document, and willingness to comply with follow-up schedule
Exclusion Criteria
- •Female is of childbearing potential
- •Life expectancy of less than 1 year
- •Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
- •Acutely ruptured or instable aneurysm or an acute vascular injury due to trauma or infected penetrating ulcers of the aorta.
- •Patient with an increased risk for aneurysm rupture during the procedure.
- •Patient whose arterial access site is not anticipated to accommodate the access of the Nexus™ Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture)
- •Patients with severe atherosclerosis or intraluminal thrombus of the aorta or in the BCT
- •Patient is suffering from unstable angina or NYHA classification III and IV and/or ASA classification IV and above.
- •Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation
- •Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
Outcomes
Primary Outcomes
Safety: Device related mortality at 30 days post implantation
Time Frame: 30 days
Secondary Outcomes
- Safety: Device related re-intervention within 1 year from implantation(1 year)