Thoracic Aortic DiseasesNexusSBNCT03208504
The Single Branch NEXUS™ Clinical Study
A study testing Nexus™ Aortic Arch Stent graft in people with Thoracic Aortic Diseases, run by Endospan Ltd. at 1 site in Germany.
Trial summary
A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Thoracic Aortic Diseases
- What is being tested?
- Nexus™ Aortic Arch Stent graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 27 Nov 2017to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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.
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- 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
- 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. Medical management of patients undergoing endovascular procedures is required for several different reasons. Patients with Aortic pathologies usually have an increased risk of cardiovascular death, necessitating treatment to reduce the overall risk for cardiovascular events. Treatment is in-line with the medical management of coronary artery disease including anti-platelet therapy and sometimes statins. Anti-platelet therapy is also mandatory to prevent complications such as graft-limb thrombosis and peripheral arterial disease (PAD), which is common in such patients.
- 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. The main factors are: immunodepression at the site of the endovascular procedure, treatment of pseudoaneurysms and mycotic aneurysms, presence of neoplasms and use of corticosteroids.
- Acute renal failure; chronic renal failure (including dialysis); Creatinine > 2.00 mg/dl or > 182 umol/L
- Patients already treated with an aortic stent graft
- Patient who underwent major surgery or interventional procedure in the last three months.
- Patients placed in an institution by authorities or court according to cf. sec 20 para. 1 sentence 4 no. 3 MPG and sec 28d, para 1, sentence 2.
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: A Multi-center Prospective Open-Label Non-Randomized Clinical Study to Evaluate the Safety and Performance of the Single Branch Nexus™ Aortic Arch Stent Graft System.
A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years.
Read the detailed description
The purpose of the study is to evaluate the safety and performance of the Single Branch Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone2). The investigational device is the Single Branch Nexus™ Aortic Arch Stent Graft System and its designated Delivery System.
Subject population: ten (10) subjects diagnosed with thoracic aortic disease involving the aortic arch, and who have appropriate anatomy to accommodate the Single Branch Nexus™ delivery system in an endovascular procedure. The study will be conducted in 2 clinical sites in Germany.
- Conditions
- Thoracic Aortic Diseases
- Being tested
- Nexus™ Aortic Arch Stent graft
- Keywords
- Thoracic Aortic Disease, Thoracic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexus™ Aortic Arch Stent graftDevice
surgical implantation of Nexus™ Aortic Arch Stent graft
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All subjects in treatment arm will be implanted with the Single Branch Nexus™ Aortic Arch Stent graft System. Receives: Device: Nexus™ Aortic Arch Stent graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 30 days post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start27 Nov 2017
- Primary completion16 Feb 2018
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endospan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Kleine, Study director, Endospan Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208504
- Sponsor's protocol ID
- CIP005
- Acronym
- NexusSB
- Status last verified
- Feb 2023
- First submitted
- 28 Jun 2017
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Open-Label Non-Randomized Clinical Study to Evaluate the Safety and Performance of the Single Branch Nexus™ Aortic Arch Stent Graft System.
- ClinicalTrials.gov ID
- NCT03208504
- Acronym / sponsor ID
- NexusSB / CIP005
- Conditions
- Thoracic Aortic Diseases
- Keywords
- Thoracic Aortic Disease, Thoracic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Endospan Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years.
Detailed description
The purpose of the study is to evaluate the safety and performance of the Single Branch Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone2). The investigational device is the Single Branch Nexus™ Aortic Arch Stent Graft System and its designated Delivery System.
Subject population: ten (10) subjects diagnosed with thoracic aortic disease involving the aortic arch, and who have appropriate anatomy to accommodate the Single Branch Nexus™ delivery system in an endovascular procedure. The study will be conducted in 2 clinical sites in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Nexus™ Aortic Arch Stent graftAll subjects in treatment arm will be implanted with the Single Branch Nexus™ Aortic Arch Stent graft System. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexus™ Aortic Arch Stent graftsurgical implantation of Nexus™ Aortic Arch Stent graft | Device | Treatment |
Primary outcome
Primary Safety Endpoint - proportion of patients free from MAEs within 30 days
Time frame: 30 days post implantation
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).
Primary Performance Endpoint -Assessment of the rate of successful disease treatment at 30 days
Time frame: 30 days post implantation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Kleine study director
Endospan Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nexus™ Aortic Arch Stent graft in people with Thoracic Aortic Diseases, run by Endospan Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint - proportion of patients free from MAEs within 30 days (time frame: 30 days post implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.