Back to resultsVenclose RF Ablation System for the Treatment of IPVs
Primary Purpose
Chronic Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Patient is >= 18 years.
- IPVs to be treated have an outward flow duration of >= 0.5 seconds immediately after release of manual distal compression with patient standing or in Reverse Trendelenburg.
- IPV(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle.
- Has been diagnosed with refractory symptomatic disease attributable to the IPV to be treated.
- Is able to ambulate.
- Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
- Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.
Exclusion Criteria:
- Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
- Has thrombus in the vein segment to be treated.
- Has untreated critical limb ischemia from peripheral arterial disease.
- Is undergoing active anticoagulant therapy for Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
- Patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively.
- Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
- Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
- Has a condition, judged by the treating physician, that may jeopardize the patient's well-being and/or confound the results or the soundness of the study.
- Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 30 days following the study procedure.
- Is participating in another clinical study that is contraindicated to the treatment or outcomes of this investigation
Sites / Locations
- Vein Center of East Texas at CardioStream
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single-arm: Endovascular thermal ablation in IPV
Arm Description
Outcomes
Primary Outcome Measures
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Effectiveness: Successful Access and Entry Into the IPV
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Secondary Outcome Measures
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04386785
Brief Title
Venclose RF Ablation System for the Treatment of IPVs
Official Title
Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2020 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
May 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venclose, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-arm: Endovascular thermal ablation in IPV
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins
Intervention Description
The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Primary Outcome Measure Information:
Title
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Description
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Time Frame
3-day post-procedure
Title
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Description
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Time Frame
15-day post-procedure
Title
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Description
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Time Frame
30-day post-procedure
Title
Effectiveness: Technical Success
Description
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Time Frame
Day of procedure
Title
Effectiveness: Successful Access and Entry Into the IPV
Description
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Time Frame
3-day post ablation
Title
Effectiveness: Technical Success
Description
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Time Frame
15-day post ablation
Title
Effectiveness: Technical Success
Description
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Time Frame
30-day post ablation
Secondary Outcome Measure Information:
Title
Acute Ablation Success
Description
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Time Frame
3-day post-procedure follow-up
Title
Acute Ablation Success
Description
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Time Frame
15-day post-procedure
Title
Acute Ablation Success
Description
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Time Frame
30-day post-procedure
Title
Reflux
Description
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Time Frame
3-day post-procedure
Title
Reflux
Description
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Time Frame
15-day post-procedure
Title
Reflux
Description
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Time Frame
30-day post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is >= 18 years.
IPVs to be treated have an outward flow duration of >= 0.5 seconds immediately after release of manual distal compression with patient standing or in Reverse Trendelenburg.
IPV(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle.
Has been diagnosed with refractory symptomatic disease attributable to the IPV to be treated.
Is able to ambulate.
Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.
Exclusion Criteria:
Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
Has thrombus in the vein segment to be treated.
Has untreated critical limb ischemia from peripheral arterial disease.
Is undergoing active anticoagulant therapy for Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
Patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively.
Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
Has a condition, judged by the treating physician, that may jeopardize the patient's well-being and/or confound the results or the soundness of the study.
Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 30 days following the study procedure.
Is participating in another clinical study that is contraindicated to the treatment or outcomes of this investigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Carr, MD
Organizational Affiliation
Vein Center of East Texas at CardioStream
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vein Center of East Texas at CardioStream
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Venclose RF Ablation System for the Treatment of IPVs
We'll reach out to this number within 24 hrs