NCT04253301

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2020Jan 2027

Study Start

First participant enrolled

January 15, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Expected
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

January 31, 2020

Last Update Submit

September 15, 2021

Conditions

Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events

    Number of Major Adverse Events

    30 Days

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects will have the InnoVein Valve implanted

Device: InnoVein Valve Treatment

Interventions

InnoVein Valve TreatmentDEVICE

Subjects will have the InnoVein Valve implanted

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hollywood Private Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

Flinders

Adelaide, Australia

RECRUITING

Central Study Contacts

InnoVen Data Management

CONTACT

650-302-0847IM-CP-2001@innoveinmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

January 15, 2020

Primary Completion

February 15, 2022

Study Completion (Estimated)

January 15, 2027

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)