NEXUS™ Aortic Arch Stent Graft System First In Man Study

Not Applicable

Completed

• Conditions: Thoracic Aortic Arch Disease; Thoracic Aortic Aneurysm
• Interventions: Device: Stent Graft Placement (Nexus)

• Registration Number: NCT02365454
• Lead Sponsor: Endospan Ltd.

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-02-11
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-19
• Primary Completion: 2018-11
• Study Completion: 2023-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Male and female age ≥ 18.
• 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.
• Patient with a contraindication to undergo angiography
• Patient with known sensitivities or allergies to the device materials- Nitinol and polyester
• Clinical conditions that severely inhibit x-ray visualization of the Aorta.
• Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)
• Patient has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator
• Patient has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3).
• Patients who have the condition that threatens to infect the stent graft.
• Acute renal failure; chronic renal failure (excluding dialysis); Creatinine > 2.00 mg/dl or > 182 umol/L
• Patient underwent major surgery or interventional procedure in the last three months.
• Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.
• Active participation in another clinical trial that is reasonable to conflict with the NexusTM study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracic Aortic Disease Single Arm Study	Stent Graft Placement (Nexus)	Thoracic Aortic Disease treated by Stent Graft Placement

Primary Outcome Measures

Name	Time	Method
Safety: Device related mortality at 30 days post implantation	30 days

Secondary Outcome Measures

Name	Time	Method
Safety: Device related re-intervention within 1 year from implantation	1 year

Trial Locations

Locations (4)

San Filippo Neri Hospital; 🇮🇹 Rome, Italy

Faculty Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Czechia

Klinic Hirslanden; 🇨🇭 Zürich, Witellikerstrasse 40, Switzerland

Zurich University Hospital; 🇨🇭 Zurich, Switzerland