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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04253301




Registration number
NCT04253301
Ethics application status
Date submitted
31/01/2020
Date registered
5/02/2020

Titles & IDs
Public title
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Scientific title
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Secondary ID [1] 0 0
IM-CP-2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Venous Insufficiency 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
Interventional
Description of intervention(s) / exposure
Treatment: Devices - InnoVein Valve Treatment

Experimental: Treatment - Subjects will have the InnoVein Valve implanted


Treatment: Devices: InnoVein Valve Treatment
Subjects will have the InnoVein Valve implanted
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events
Timepoint [1] 0 0
30 Days

Eligibility
Key inclusion criteria
Key

* Willing and able to provide written Informed Consent
* Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein
* Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication
* Life expectancy >1yr
* Reflux time >1s in the superficial femoral and/or popliteal vein

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any prior deep vein intervention within 6 months prior to the Index Procedure
* History of 2+ DVTs
* Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC
* Current IVC Placement
* History of pulmonary embolism within 6 months
* Conditions that increase the risk of device thrombosis or patient bleeding
* Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure
* Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/01/2027
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 0 0
Flinders - Adelaide
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment postcode(s) [2] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
InnoVein
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
InnoVen Data Management
Address 0 0
Country 0 0
Phone 0 0
650-302-0847
Fax 0 0
Email 0 0
IM-CP-2001@innoveinmedical.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT04253301