Venclose RF Ablation System for the Treatment of IPVs

Chronic Venous Insufficiency Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386785
• Other study ID #: CL-VAV-001
• Status: Completed
• Phase: N/A
• Start date: May 23, 2020
• Est. completion date: May 13, 2021

Study information

• Verified date: May 2022
• Source: Venclose, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Vein Center of East Texas at CardioStream	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Venclose, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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