Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System - INFINITE-US (INFINITE-US)
Primary Purpose
Chronic Venous Insufficiency (CVI), Deep Vein Reflux
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)
Sponsored by
About this trial
This is an interventional device feasibility trial for Chronic Venous Insufficiency (CVI)
Eligibility Criteria
Key Inclusion Criteria
- Failed at least 6 months of conservative therapy at some point during the course of their CVI management (symptoms not adequately resolved or patient non-compliant/unable to tolerate)
- Deep system venous reflux characterized by >1 second reflux time in two vein segments (vein segments defined as: proximal femoral, distal femoral, and popliteal), as assessed by duplex ultrasound (DUS) with patient in the standing position
Presence of at least two potential target sites within a target vessel as assessed preliminarily by DUS, with a target site being defined as a segment within the femoral or popliteal vein that is:
7mm to 11mm in luminal diameter and at least 3cm long and absent features that, in the Investigator's opinion, would preclude formation of a monocuspid valve (at any orientation).
- In the Investigator's opinion, the subject is a good candidate for treatment with the BlueLeaf System based on their symptoms, quality of life, anatomy, and the likelihood of benefit from continued conservative therapy
Key Exclusion Criteria:
- Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms
- Acute deep venous thrombosis (DVT) within 1 year of consent
- Deep venous intervention (includes stenting) in the target limb or outflow vessels within 3 months of consent
- Flow-limiting venous outflow obstruction central to the intended target sites, defined by a common femoral vein duplex exam found to have a continuous waveform without respiratory variation
- Contraindications to all protocol specified anticoagulation options
- Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot be adequately managed/controlled with medication)
- Women on long-term oral contraceptives
- Non-ambulatory patients
- Significant peripheral arterial disease with an ankle-brachial index of < 0.70 or with incompressible vessels
- New York Heart Association Class III or IV heart failure
- Patients with a history of right heart failure occurring as a consequence of, for example, biventricular failure, intrinsic pulmonary disease, chronic thromboembolic pulmonary hypertension, and other etiologies that result in elevated right-sided pressures.
- Active systemic infection
- Invasive surgical procedure within the last 3 months that in the Investigator's opinion would interfere with the study procedure or results
- Chronic renal insufficiency with creatinine level of ≥ 2mg/dL
- Hemoglobin level < 9.0 mg/dL
- Platelet count < 50,000 or > 1,000,000/mm3
- Total white blood cell count < 3,000/mm3
- Subject is enrolled in another clinical study that, in the opinion of the Investigator, may c
- Comorbidity risks or other concerns which, in the opinion of the Investigator, either limits longevity or likelihood of complying with the protocol and its prescribed follow up (e.g. recent cancer or stroke); or precludes patient from being transitioned to open surgery if complication requiring surgical intervention occurs during the procedure (such as severe vein laceration).
Sites / Locations
- The Vascular Experts
- NYU Langone Medical Center
- University of North Carolina at Chapel Hill
- Allegheny General Hospital
- Sentara Vascular Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational
Arm Description
Subjects will be treated with the investigational device and followed per protocol.
Outcomes
Primary Outcome Measures
Primary Safety Endpoint: The number of subjects experiencing a major adverse event (MAE), composed of the following
Symptomatic pulmonary embolism
DVT anywhere in the deep venous system of the treatment limb
Occlusive valve pocket thrombus (VPT)
Non-occlusive stenosis in the target vessel (including due to scarring, inflammation, VPT, etc.) leading to persistent worsening of symptoms attributable to venous flow obstruction, or requiring post-procedural surgical or endovascular re-intervention
Device or procedure-related venous or arterial injury in the treated limb (such as Arteriovenous Fistula (AVF's), bleeding, pseudo aneurysm) leading to worsening of symptoms that require post-procedural surgical or endovascular re-intervention or requiring transfusion of more than 2 units of blood. (Note: Peri-procedural stiches placed to assist with closure of the access site will not be characterized as a primary safety failure.)
Device or procedure-related death
Change in revised Venous Clinical Severity Score (rVCSS) from baseline
The rVCSS is an evaluative instrument that is used serially to assess changes in disease severity over time, as well as, in response to treatment for a patient. Scoring is from 0 to 30, and a decrease in the score indicates clinical improvement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04225806
Brief Title
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System - INFINITE-US
Acronym
INFINITE-US
Official Title
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Project suspended by Sponsor
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intervene, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective, non-randomized, multicenter pre-market early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity
Detailed Description
The purpose of this early feasibility study is to provide information on the BlueLeaf System for the formation of one or more autogenous vein valves constructed from the vein wall of the femoral and/or popliteal vein, in subjects with CVI and who meet the specified eligibility criteria. In particular, the safety and technical feasibility of the procedure will be validated in patients in the United States, including the procedural steps, operator technique, and subject characteristics. The study will assess the safety and effectiveness of the study device acutely and through 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency (CVI), Deep Vein Reflux
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational
Arm Type
Experimental
Arm Description
Subjects will be treated with the investigational device and followed per protocol.
Intervention Type
Device
Intervention Name(s)
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)
Intervention Description
The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint: The number of subjects experiencing a major adverse event (MAE), composed of the following
Description
Symptomatic pulmonary embolism
DVT anywhere in the deep venous system of the treatment limb
Occlusive valve pocket thrombus (VPT)
Non-occlusive stenosis in the target vessel (including due to scarring, inflammation, VPT, etc.) leading to persistent worsening of symptoms attributable to venous flow obstruction, or requiring post-procedural surgical or endovascular re-intervention
Device or procedure-related venous or arterial injury in the treated limb (such as Arteriovenous Fistula (AVF's), bleeding, pseudo aneurysm) leading to worsening of symptoms that require post-procedural surgical or endovascular re-intervention or requiring transfusion of more than 2 units of blood. (Note: Peri-procedural stiches placed to assist with closure of the access site will not be characterized as a primary safety failure.)
Device or procedure-related death
Time Frame
30 day follow up
Title
Change in revised Venous Clinical Severity Score (rVCSS) from baseline
Description
The rVCSS is an evaluative instrument that is used serially to assess changes in disease severity over time, as well as, in response to treatment for a patient. Scoring is from 0 to 30, and a decrease in the score indicates clinical improvement.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria
Failed at least 6 months of conservative therapy at some point during the course of their CVI management (symptoms not adequately resolved or patient non-compliant/unable to tolerate)
Deep system venous reflux characterized by >1 second reflux time in two vein segments (vein segments defined as: proximal femoral, distal femoral, and popliteal), as assessed by duplex ultrasound (DUS) with patient in the standing position
Presence of at least two potential target sites within a target vessel as assessed preliminarily by DUS, with a target site being defined as a segment within the femoral or popliteal vein that is:
7mm to 11mm in luminal diameter and at least 3cm long and absent features that, in the Investigator's opinion, would preclude formation of a monocuspid valve (at any orientation).
In the Investigator's opinion, the subject is a good candidate for treatment with the BlueLeaf System based on their symptoms, quality of life, anatomy, and the likelihood of benefit from continued conservative therapy
Key Exclusion Criteria:
Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms
Acute deep venous thrombosis (DVT) within 1 year of consent
Deep venous intervention (includes stenting) in the target limb or outflow vessels within 3 months of consent
Flow-limiting venous outflow obstruction central to the intended target sites, defined by a common femoral vein duplex exam found to have a continuous waveform without respiratory variation
Contraindications to all protocol specified anticoagulation options
Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot be adequately managed/controlled with medication)
Women on long-term oral contraceptives
Non-ambulatory patients
Significant peripheral arterial disease with an ankle-brachial index of < 0.70 or with incompressible vessels
New York Heart Association Class III or IV heart failure
Patients with a history of right heart failure occurring as a consequence of, for example, biventricular failure, intrinsic pulmonary disease, chronic thromboembolic pulmonary hypertension, and other etiologies that result in elevated right-sided pressures.
Active systemic infection
Invasive surgical procedure within the last 3 months that in the Investigator's opinion would interfere with the study procedure or results
Chronic renal insufficiency with creatinine level of ≥ 2mg/dL
Hemoglobin level < 9.0 mg/dL
Platelet count < 50,000 or > 1,000,000/mm3
Total white blood cell count < 3,000/mm3
Subject is enrolled in another clinical study that, in the opinion of the Investigator, may c
Comorbidity risks or other concerns which, in the opinion of the Investigator, either limits longevity or likelihood of complying with the protocol and its prescribed follow up (e.g. recent cancer or stroke); or precludes patient from being transitioned to open surgery if complication requiring surgical intervention occurs during the procedure (such as severe vein laceration).
Facility Information:
Facility Name
The Vascular Experts
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Sentara Vascular Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System - INFINITE-US
We'll reach out to this number within 24 hrs