Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Primary Purpose
Chronic Venous Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
InnoVein Valve Treatment
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Hollywood Private HospitalRecruiting
- Sir Charles Gairdner HospitalRecruiting
- FlindersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Subjects will have the InnoVein Valve implanted
Outcomes
Primary Outcome Measures
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events
Number of Major Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04253301
Brief Title
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Official Title
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Anticipated)
Study Completion Date
January 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InnoVein
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects will have the InnoVein Valve implanted
Intervention Type
Device
Intervention Name(s)
InnoVein Valve Treatment
Intervention Description
Subjects will have the InnoVein Valve implanted
Primary Outcome Measure Information:
Title
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events
Description
Number of Major Adverse Events
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
InnoVen Data Management
Phone
650-302-0847
Email
IM-CP-2001@innoveinmedical.com
Facility Information:
Facility Name
Hollywood Private Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krys Hiscock, RN
Phone
0474 769 593
Email
nursing@affinityresearch.com.au
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Jansen, MD
Phone
+61 8 6151 0820
Email
JShirley.Jansen@health.wa.gov.au
Facility Name
Flinders
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Toomey
Phone
08 82045445
Email
Melanie.Toomey@sa.gov.au
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
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