NEXUS™ Aortic Arch Stent Graft System First In Man Study

NCT02365454 | Completed

• 1 other identifier: CIP004.00
• Study Type: interventional
• Target: 18
• Locations: 3 countries
• Sites: 4

Brief Summary

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

Conditions

Thoracic Aortic Arch Disease; Thoracic Aortic Aneurysm

Keywords

TAA

Outcome Measures

Primary Outcomes (1)

• Safety: Device related mortality at 30 days post implantation

  30 days

Secondary Outcomes (1)

• Safety: Device related re-intervention within 1 year from implantation

  1 year

Other Outcomes (1)

• Performance: Assess the rate of successful disease treatment at 30 days post implantation

  30 days

Study Arms (1)

Thoracic Aortic Disease Single Arm Study

EXPERIMENTAL

Thoracic Aortic Disease treated by Stent Graft Placement

Device: Stent Graft Placement (Nexus)

Interventions

Stent Graft Placement (Nexus) 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.

Thoracic Aortic Disease Single Arm Study

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endospan Ltd.: lead

Study Sites (4)

Faculty Hospital Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

San Filippo Neri Hospital

Rome, 00135, Italy

Location

Klinic Hirslanden

Zurich, Witellikerstrasse 40, CH-8032, Switzerland

Location

Zurich University Hospital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Mario Lachat, Prof. MD

  Klinic Hirslanden, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 19, 2015
• Study Start: August 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: June 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CH (2); CZ (1); IT (1)