NCT04253301 Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
| NCT ID | NCT04253301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | InnoVein |
| Condition | Chronic Venous Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2020-01-15 |
| Primary Completion | 2022-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2020-01-15 with a primary completion date of 2022-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Key Inclusion Criteria: * 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: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04253301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Venous Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04253301 currently recruiting?
Yes, NCT04253301 is actively recruiting participants. Contact the research team at IM-CP-2001@innoveinmedical.com for enrollment information.
Where is the NCT04253301 trial being conducted?
This trial is being conducted at Nedlands, Australia, Nedlands, Australia, Adelaide, Australia.
Who is sponsoring the NCT04253301 clinical trial?
NCT04253301 is sponsored by InnoVein. The trial plans to enroll 5 participants.