Clinical trial NCT02365454: NEXUS™ Aortic Arch Stent Graft System First In Man Study
Official title: Feasibility Clinical Study to Evaluate the Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Aortic Arch Disease
Thoracic Aortic Aneurysm
Keywords: TAA
Lead sponsor: Endospan Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety: Device related mortality at 30 days post implantation
timeFrame: 30 days
Secondary outcomes:
measure: Safety: Device related re-intervention within 1 year from implantation
timeFrame: 1 year
Other outcomes:
measure: Performance: Assess the rate of successful disease treatment at 30 days post implantation
timeFrame: 30 days
Locations:
city: Hradec Králové
country: Czechia
facility: Faculty Hospital Hradec Kralove
city: Rome
country: Italy
facility: San Filippo Neri Hospital
city: Zürich
country: Switzerland
facility: Klinic Hirslanden
state: Witellikerstrasse 40
city: Zurich
country: Switzerland
facility: Zurich University Hospital
Study officials:
affiliation: Klinic Hirslanden, Switzerland
name: Mario Lachat, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: