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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03420066




Registration number
NCT03420066
Ethics application status
Date submitted
28/01/2018
Date registered
5/02/2018

Titles & IDs
Public title
The NEXUS™ Compassionate Use Data Collection Study
Scientific title
NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures
Secondary ID [1] 0 0
CIP008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Arch Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Retrospective data collection

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)


Other interventions: Retrospective data collection
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Evaluation Criteria
Assessment method [1] 0 0
Device related mortality at 30 days post implantation based on review of medical charts by the Investigators
Timepoint [1] 0 0
within 30 days post implantation
Primary outcome [2] 0 0
Performance Evaluation Criteria
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
within 30 days post implantation
Secondary outcome [1] 0 0
Secondary Safety Evaluation Criteria
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
within 1 year post-implantation

Eligibility
Key inclusion criteria
* 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2023
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Lazio
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
Switzerland
State/province [3] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endospan Ltd.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03420066