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In Situ Valve Formation
BlueLeaf System for Chronic Venous Insufficiency (INFINITE-OUS Trial)
N/A
Recruiting
Research Sponsored by Intervene, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of at least one target site within the target vessel
Failed compression therapy of at least 6 months' duration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
INFINITE-OUS Trial Summary
This trial will test a new device to treat CVI, a condition that causes pain and swelling in the legs. The device will be evaluated for safety and effectiveness.
Who is the study for?
This trial is for people with chronic venous insufficiency (CVI) who have symptoms and haven't improved after at least 6 months of compression therapy. They should have a specific type of vein reflux and not be pregnant, recently had a stroke or deep vein thrombosis, or suffer from severe kidney disease, blood disorders, or significant artery disease in the legs.Check my eligibility
What is being tested?
The BlueLeaf System is being tested to see if it can effectively treat CVI by restoring proper function to veins in the leg. The study will look at how safe it is and how well it works for patients who meet certain health criteria.See study design
What are the potential side effects?
While the specific side effects are not listed here, common risks associated with medical procedures like this may include pain at the site of intervention, bleeding, infection risk increase, possible damage to nearby nerves or vessels.
INFINITE-OUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one area in my blood vessel that can be treated.
Select...
I have tried compression therapy for over 6 months without improvement.
Select...
I have leg vein problems graded between 3 to 6.
INFINITE-OUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.
Percent decrease in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 30-day follow-up imaging study
INFINITE-OUS Trial Design
1Treatment groups
Experimental Treatment
Group I: BlueLeaf SystemExperimental Treatment1 Intervention
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
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Who is running the clinical trial?
Intervene, Inc.Lead Sponsor
3 Previous Clinical Trials
17 Total Patients Enrolled
Fletcher WilsonStudy DirectorIntervene, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have untreated vein problems that might be causing my symptoms.I have not had any vein procedures in the limb of interest in the last 6 months.I have not had a stroke in the past 6 months.I cannot walk by myself.I have a blockage in a major vein near the area needing treatment.My vein does not allow enough blood flow when pressed.I am not pregnant or breastfeeding.My creatinine level is 2mg/dL or higher, indicating kidney issues.I have severe leg artery disease measured by a specific test.My leg vein disease is severe and may not allow for successful vein treatment.Your hemoglobin level is less than 9.0 mg/dL.Your total white blood cell count is less than 3,000 per cubic millimeter.I have at least one area in my blood vessel that can be treated.Your platelet count is too low or too high.I have tried compression therapy for over 6 months without improvement.I have had a deep vein clot in the last 3 months.You have a condition where blood flows the wrong way in your veins for more than 1 second.I have leg vein problems graded between 3 to 6.
Research Study Groups:
This trial has the following groups:- Group 1: BlueLeaf System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being invited to join this clinical investigation?
"Affirmative. The clinical trial, first posted on November 2nd 2017 and last revised on September 8th 2021, is currently seeking participants. Approximately 15 individuals are required to be recruited from 1 medical facility."
Answered by AI
What is the upper boundary with respect to participants in this medical experiment?
"Indeed, the clinicaltrials.gov resource affirms that this trial is actively seeking participants. Initially posted on November 2nd 2017 and most recently updated on September 8th 2021, 15 patients are required from 1 medical site for proper recruitment to occur."
Answered by AI
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