Chronic Venous InsufficiencyNCT04253301
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
A study testing InnoVein Valve Treatment in people with Chronic Venous Insufficiency, run by InnoVein at 3 sites in Australia.
Trial summary
This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- InnoVein Valve Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesAustralia
- Study dates
- 15 Jan 2020to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Flinders
Adelaide
Melanie Toomey, 08 82045445, Melanie.Toomey@sa.gov.au
- Recruiting
Hollywood Private Hospital
Nedlands, Western Australia, 6009
Krys Hiscock, RN, 0474 769 593, nursing@affinityresearch.com.au
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Shirley Jansen, MD, +61 8 6151 0820, JShirley.Jansen@health.wa.gov.au
About this study
This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.
Read the detailed description
Chronic Venous Insufficiency occurs when the venous wall and/or valves in the leg veins are not working effectively, making it difficult for blood to return to the heart from the legs.The core etiology of the disease stems from increased venous pressure and incompetent venous valves leading to regurgitation of blood that accumulates in the legs. It has been shown that implantation or recreation of a functional valve can lead to clearance of excess blood and resolution of symptoms.
The InnoVein Valve and Delivery System is a new, investigational biocompatible valve intended to support natural flow in vessels in patients with Chronic Venous Insufficiency. The purpose of this study is to assess the safety of the InnoVein Valve and Delivery System for treatment of Chronic Venous Insufficiency.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- InnoVein Valve Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnoVein Valve TreatmentDevice
Subjects will have the InnoVein Valve implanted
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects will have the InnoVein Valve implanted Receives: Device: InnoVein Valve Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events
Number of Major Adverse Events
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Jan 2020
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies 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
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoVein
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253301
- Sponsor's protocol ID
- IM-CP-2001
- Status last verified
- Sep 2021
- First submitted
- 31 Jan 2020
- Last updated
- 17 Sep 2021
- 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 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT04253301
- Acronym / sponsor ID
- IM-CP-2001
- Conditions
- Chronic Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- InnoVeinIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 5 Feb 2020 (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.
This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.
Detailed description
Chronic Venous Insufficiency occurs when the venous wall and/or valves in the leg veins are not working effectively, making it difficult for blood to return to the heart from the legs.The core etiology of the disease stems from increased venous pressure and incompetent venous valves leading to regurgitation of blood that accumulates in the legs. It has been shown that implantation or recreation of a functional valve can lead to clearance of excess blood and resolution of symptoms.
The InnoVein Valve and Delivery System is a new, investigational biocompatible valve intended to support natural flow in vessels in patients with Chronic Venous Insufficiency. The purpose of this study is to assess the safety of the InnoVein Valve and Delivery System for treatment of Chronic Venous Insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: InnoVein Valve TreatmentSubjects will have the InnoVein Valve implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| InnoVein Valve TreatmentSubjects will have the InnoVein Valve implanted | Device | Treatment |
Primary outcome
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events
Time frame: 30 Days
Number of Major Adverse Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InnoVein Valve Treatment in people with Chronic Venous Insufficiency, run by InnoVein at 3 sites in Australia.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact InnoVen Data Management (650-302-0847, IM-CP-2001@innoveinmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events (time frame: 30 Days). 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 17 Sep 2021.