Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-OUS)

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

Study Overview

• Status: Terminated
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Device: BlueLeaf System

Detailed Description

Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver Coastal Health Research Institute
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
  • Hamilton, New Zealand
    • Clinical Trials New Zealand Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
• Failed compression therapy of at least 6 months' duration;
• Deep system venous reflux characterized by >1 second reflux time;
• Presence of at least one target site within the target vessel.

Exclusion Criteria:

• Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
• Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
• Significant peripheral arterial disease with an ankle-brachial index of <0.50 or with incompressible vessels;
• Acute deep venous thrombosis (DVT) within 3 months of consent;
• History of stroke within the last 6 months;
• Flow-limiting venous outflow obstruction central to the intended target sites;
• Insufficient inflow through the treatment vein upon manual augmentation;
• Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
• Chronic renal insufficiency with creatinine level of ≥2mg/dL;
• Hemoglobin level <9.0 mg/dL;
• Platelet count <50,000 or >1,000,000 per mm3;
• Total white blood cell count <3,000/mm3;
• Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
• Non-ambulatory patients;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BlueLeaf System; The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.	Device: BlueLeaf System; The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment	Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up	Baseline, 7-day, 30-day
Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)	Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit	30-day post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment	Rates (count) of participants with DVTs in the target vessel at the 90-day and 210-day follow-up assessed by follow-up imaging	90-day, 210-day
Change in Reflux Time (RT) in the Primary Treated Vein Segment	Assessment of the reflux time in the primary treated vein segment. Change in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 90-day and 210-day follow-up visits were assessed; the outcome is reported as the % change in the reflux time from Baseline	90-day, 210-day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Technical Success	Procedure technical success is defined as delivery of the system to the target vessel and formation of at least one mobile autogenous valve (as measured with intravascular ultrasound (IVUS) or venography following valve formation) without target vessel occlusion at the conclusion of the index procedure	Procedure
Average Revised Venous Clinical Severity Score (rVCSS)	Assessment of the average (mean) rVCSS at Baseline, 30D and 90D. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, >/=3), duration of ulcers (<3 months, >3 months but <1 year, not healed for >1 year), active ulcer size (diameter <2cm, diameter 2-6cm, and diameter >6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). A higher total score would indicate a worse outcome (total score can range from 0 to 30); the outcome is reported as the average (mean) scores at Baseline, 30D and 90D.	Baseline, 30-day, 90-day
Change in Revised Venous Clinical Severity Score (rVCSS)	Assessment of the average (mean) change in rVCSS at 30D and 90D compared to Baseline. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, >/=3), duration of ulcers (<3 months, >3 months but <1 year, not healed for >1 year), active ulcer size (diameter <2cm, diameter 2-6cm, and diameter >6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). An increase in total score over time would indicate a worse outcome; the outcome is reported as the average (mean) numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Revised Venous Clinical Severity Score").	30-day, 90-day
Average Villalta Scale Score	Assessment of the average (mean) Villalta Scale Score at Baseline, 30D, and 90D. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average (mean) scores at Baseline, 30D and 90D. A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease.	Baseline, 30-day, 90-day
Change in Villalta Scale Score	Assessment of average (mean) change in Villalta Scale Score at 30D and 90D compared to Baseline. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Villalta Scale Score"). A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease.	30-day, 90-day
Average VEINES-QoL/Sym Score	Assessment of the average (mean) VEINES-QoL/Sym Score at Baseline, 30D, 90D and 210D. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). VEINES-QoL/Sym scores can range from 0-100, where higher scores indicate better outcomes (higher quality of life and less severe symptoms). The calculated mean VEINES-QoL/Sym scores at 30D, 90D and 210D post-procedure are provided.	Baseline, 30-day, 90-day, 210-day
Change in VEINES-QoL/Sym Score	Assessment of the change in the median (min, max) VEINES-QoL/Sym Score at 30D, 90D and 210D compared to Baseline. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). The outcome is reported as the change in median (min, max) score at 30D, 90D and 210D compared to the Baseline score (for Baseline scores refer to outcome measure "Average VEINES-QoL/Sym Score").	30-day, 90-day, 210-day

Collaborators and Investigators

• Sponsor: Intervene, Inc.
• Investigators: Study Director: Jeff Elkins, Intervene, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: CLN003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes