NEXUS™ Aortic Arch Stent Graft System First In Man Study

NCT ID: NCT02365454

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2023-06-30

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.

Conditions

Thoracic Aortic Arch Disease; Thoracic Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thoracic Aortic Disease Single Arm Study

Thoracic Aortic Disease treated by Stent Graft Placement

Group Type: EXPERIMENTAL

Stent Graft Placement (Nexus)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endospan Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Lachat, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Klinic Hirslanden, Switzerland

Locations

Faculty Hospital Hradec Kralove

Hradec Králové, , Czechia

San Filippo Neri Hospital

Rome, , Italy

Klinic Hirslanden

Zurich, Witellikerstrasse 40, Switzerland

Zurich University Hospital

Zurich, , Switzerland

Countries

Czechia; Italy; Switzerland

Other Identifiers

CIP004.00

Identifier Type: -

Identifier Source: org_study_id