The Single Branch NEXUS™ Clinical Study

NCT03208504 | Completed DMC

• 1 other identifier: CIP005
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thoracic Aortic Diseases

Keywords

Thoracic Aortic Disease; Thoracic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - proportion of patients free from MAEs within 30 days

  Proportion of subjects free from MAEs within 30 days post implantation. MAE is defined as: all-cause mortality, myocardial infarction, renal failure, paraplegia, stroke and bowel ischemia for which a causal relationship with the device cannot be excluded on the basis of the adjudication of the independent Data Monitoring Committee (DMC).

  30 days post implantation

• Primary Performance Endpoint -Assessment of the rate of successful disease treatment at 30 days

  Assessment of the rate of successful disease treatment at 30 days post implantation, defined as: Successful delivery and deployment of the device, meaning device was deployed and located in the aortic arch isolating the diseased lesion.

  30 days post implantation

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects in treatment arm will be implanted with the Single Branch Nexus™ Aortic Arch Stent graft System.

Device: Nexus™ Aortic Arch Stent graft

Interventions

Nexus™ Aortic Arch Stent graft DEVICE

surgical implantation of Nexus™ Aortic Arch Stent graft

Treatment

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-90.
• Thoracic aortic pathology requiring landing in the aortic arch (either: zone 0, zone 1, zone2) e.g. aneurysm, stable chronic type B dissection.
• In patient with a thoracic aneurysm1: 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
• American Society of Anesthesiologists (ASA) Classification of III \& IV or if not eligible for open-repair surgery (for example previous thoracotomy)
• Patient is considered clinically and hemodynamically stable based on the discretion of the treating physicians.
• Patient is considered eligible for an elective surgery
• Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA, MRA:
• Femoral/Iliac vessel suitable for 20Fr. introducer
• Brachial/Axial Artery vessel suitable for 8Fr. Introducer
• To be eligible to receive the SB-Nexus having the following characteristics, as demonstrated on CTA/MRA:
• Access vessels, iliac/femoral \& brachial/axillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and /or accessories.
• Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation.
• Cranial Main Module landing zone (at the braceocephalic artery) ≥ 20mm
• Caudal Main Module landing zone (at the descending aorta) ≥ 30mm
• Proximal Ascending Module landing zone (at the ascending aorta) ≥ 30mm

You may not qualify if:

• Female is of childbearing potential
• Life expectancy of less than 5 years due to comorbidities
• Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
• Patient with complicated anatomy (type IV Aortic arch, mechanical valve with less than 50mm of Ascending Arch).
• Acutely ruptured or instable aneurysm or an acute vascular injury due to trauma or infected penetrating ulcers of the aorta.
• Patients with acute (unstable) dissections or mycotic aneurysms, ulcers or intramural hematoma are to be excluded from the study.
• 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 Single Branch 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 V 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. Clinical conditions that severely inhibit x-ray visualization of the Aorta like obesity, or other metal stents in proximity to the designated implantation location that can cause artifacts in the x-ray visualization

Sponsors & Collaborators

• Endospan Ltd.: lead

Study Sites (1)

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica Kleine

  Endospan Ltd.

  STUDY DIRECTOR

Study Design

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

Model Details: Prospective, open-label, non-randomized, interventional clinical study. All subjects will be treated by implantation of the Single Branch Nexus™ Aortic Arch Stent graft System.

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 5, 2017
• Study Start: November 27, 2017
• Primary Completion: February 16, 2018
• Study Completion: January 20, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)