Aortic Arch AneurysmNCT03420066
The NEXUS™ Compassionate Use Data Collection Study
An observational study of Aortic Arch Aneurysm, run by Endospan Ltd. at 4 sites in 3 countries.
Trial summary
A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Arch Aneurysm
- What is being tested?
- Retrospective data collection
- How many people
- 7 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 19 Feb 2018to 28 Nov 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will include all patients that were implanted with the Nexus device as part of the compassionate use.
Who may be able to join
- Patients for whom the Nexus implantation was initiated as part of a compassionate use procedure.
- A signed and dated Informed Consent document is available that authorizes to collect the patient's personal data following implantation of the Nexus systems and throughout the follow ups visits up to 5 years following implantation.
Who cannot join
- -There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Switzerland2 sites
Klinik Hirslanden
Zurich, CH-8032
Zurich University Hospital
Zurich, CH-8091
About this study
Official title: NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures
A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.
Read the detailed description
The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch.
Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.
- Conditions
- Aortic Arch Aneurysm
- Being tested
- Retrospective data collection
- Medical subject headings
- Aneurysm, Aortic Arch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data collectionOther
Retrospective collection of data recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use duly authorized according to country specific regulations.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective data collection | Group includes subjects that were implanted with the Nexus device as part of compassionate use procedure before joining the CIP008 study. Only intervention foreseen by CIP008 study is retrospective collection of data previously recorded as standard of care in medical charts (refer to Intervention/treatment section) Receives: Other: Retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Evaluation Criteria
Device related mortality at 30 days post implantation based on review of medical charts by the Investigators
Measured: within 30 days post implantation
Performance Evaluation Criteria
Successful disease treatment at 30 days post implantation, defined as Stent Graft positioned in the aortic arch isolating the diseased lesion based on review of medical charts by the Investigators.
Measured: within 30 days post implantation
Secondary outcomes (1)
Secondary Safety Evaluation Criteria
Device related re-intervention (e.g. due to endoleak, stent graft occlusion, clinically significant migration) within 1 year from implantation and based on review of medical charts by the Investigators.
Measured: within 1 year 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 Feb 2018
- Study start19 Feb 2018
- Primary completion14 Sep 2018
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Arch AneurysmStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endospan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420066
- Sponsor's protocol ID
- CIP008
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2018
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures
- ClinicalTrials.gov ID
- NCT03420066
- Acronym / sponsor ID
- CIP008
- Conditions
- Aortic Arch Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Endospan Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 5 Feb 2018 (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 Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.
Detailed description
The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch.
Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective data collection | – | Other: Retrospective data collectionGroup includes subjects that were implanted with the Nexus device as part of compassionate use procedure before joining the CIP008 study. Only intervention foreseen by CIP008 study is retrospective collection of data previously recorded as standard of care in medical charts (refer to Intervention/treatment section) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will include all patients that were implanted with the Nexus device as part of the compassionate use.
Key inclusion criteria (2 listed)
- Patients for whom the Nexus implantation was initiated as part of a compassionate use procedure.
- A signed and dated Informed Consent document is available that authorizes to collect the patient's personal data following implantation of the Nexus systems and throughout the follow ups visits up to 5 years following implantation.
Key exclusion criteria (1 listed)
- -There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above
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 |
|---|---|---|
| Retrospective data collectionRetrospective collection of data recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use duly authorized according to country specific regulations. | Other | Retrospective data collection |
Primary outcome
Primary Safety Evaluation Criteria
Time frame: within 30 days post implantation
Device related mortality at 30 days post implantation based on review of medical charts by the Investigators
Performance Evaluation Criteria
Time frame: within 30 days post implantation
Successful disease treatment at 30 days post implantation, defined as Stent Graft positioned in the aortic arch isolating the diseased lesion based on review of medical charts by the Investigators.
1 secondary outcome
Secondary Safety Evaluation Criteria
Time frame: within 1 year post-implantation
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 5 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Arch Aneurysm, run by Endospan Ltd. at 4 sites in 3 countries.
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 2 inclusion and 1 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, Italy, New Zealand. 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 Evaluation Criteria (time frame: within 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 5 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.