Venclose RF Ablation System for the Treatment of IPVs

Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)

A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Device: Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Tyler, Texas, United States, 75701
      • Vein Center of East Texas at CardioStream

Participation Criteria

Eligibility Criteria

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

Description

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

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: Single-arm: Endovascular thermal ablation in IPV

Device: Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-day post-procedure
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.	15-day post-procedure
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.	30-day post-procedure
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.	Day of procedure
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.	3-day post ablation
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.	15-day post ablation
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.	30-day post ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-day post-procedure follow-up
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.	15-day 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.	30-day 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.	3-day 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.	15-day 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.	30-day post-procedure

Collaborators and Investigators

• Sponsor: Venclose, Inc.
• Investigators: Principal Investigator: Jeffrey Carr, MD, Vein Center of East Texas at CardioStream

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2020
• Primary Completion (Actual): April 13, 2021
• Study Completion (Actual): May 13, 2021

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: CL-VAV-001

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