NEXUS™ Aortic Arch Stent Graft System First In Man Study

Feasibility Clinical Study to Evaluate the Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System

A multicenter, prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.

Study Overview

• Status: Completed
• Conditions: Thoracic Aortic Aneurysm; Thoracic Aortic Arch Disease
• Intervention / Treatment: Device: Stent Graft Placement (Nexus)

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Hradec Králové, Czechia, 500 05
    • Faculty Hospital Hradec Kralove
• Italy
  • Rome, Italy, 00135
    • San Filippo Neri Hospital
• Switzerland
  • Zurich, Switzerland, 8091
    • Zurich University Hospital
  • Witellikerstrasse 40
    • Zürich, Witellikerstrasse 40, Switzerland, CH-8032
      • Klinic Hirslanden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Thoracic Aortic Disease Single Arm Study; Thoracic Aortic Disease treated by Stent Graft Placement

Device: Stent Graft Placement (Nexus); The Nexus stent graft is introduced through a groin to the diseased location at the Aortic Arch. Depending on the patients anatomy and other medical considerations the physician may decide that blood flow to the sub-clavian artery and possibly also to the left carotid artery is required to be maintained via "surgical bypass grafting", either immediately, or a few days, before the implantation. In addition to the incision for introducing the investigational stent graft, two smaller access sites are required, one at the groin on the opposite side and on into the Right Arm to the Brachial Artery. This endovascular procedure will likely require full anesthesia. The entire procedure is assisted by an angiography imaging system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Device related mortality at 30 days post implantation	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Device related re-intervention within 1 year from implantation	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Performance: Assess the rate of successful disease treatment at 30 days post implantation	30 days

Collaborators and Investigators

• Sponsor: Endospan Ltd.
• Investigators: Principal Investigator: Mario Lachat, Prof. MD, Klinic Hirslanden, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimated): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: TAA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: CIP004.00