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Endovenous Valve Formation System
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System) for Chronic Venous Insufficiency (INFINITE-US Trial)
N/A
Waitlist Available
Research Sponsored by Intervene, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the BlueLeaf System, a device that creates new vein valves from a patient's own veins, in patients with chronic venous insufficiency in their legs. The goal is to see if it safely and effectively improves blood flow and reduces symptoms like swelling and pain.
Eligible Conditions
- Chronic Venous Insufficiency
- Venous insufficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in revised Venous Clinical Severity Score (rVCSS) from baseline
Primary Safety Endpoint: The number of subjects experiencing a major adverse event (MAE), composed of the following
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InvestigationalExperimental Treatment1 Intervention
Subjects will be treated with the investigational device and followed per protocol.
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Who is running the clinical trial?
Intervene, Inc.Lead Sponsor
3 Previous Clinical Trials
17 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of heart failure specifically affecting the right side of your heart, which can be caused by different conditions that increase pressure in the right side of the heart.You have tried conservative treatments for at least 6 months to manage your condition, but the symptoms did not improve or you were unable to continue the treatment.You are unable to take any of the recommended blood thinning medications listed in the study.You have severe heart failure, categorized as Class III or IV by the New York Heart Association.The doctor thinks that you are a suitable candidate for treatment with the BlueLeaf System based on your symptoms, how it affects your daily life, your body structure, and the chances of benefiting from other treatments.You have untreated problems with the veins near the surface of your skin that may be causing your symptoms.You have had a procedure in the veins of your leg within the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational
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.
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