Clinical trial NCT04386785: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency
Lead sponsor: Venclose, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Safety: AEs, SAEs, ADEs, SADEs, UADEs
timeFrame: 3-day post-procedure
measure: Safety: AEs, SAEs, ADEs, SADEs, UADEs
timeFrame: 15-day post-procedure
measure: Safety: AEs, SAEs, ADEs, SADEs, UADEs
timeFrame: 30-day post-procedure
measure: Effectiveness: Technical Success
timeFrame: Day of procedure
measure: Effectiveness: Successful Access and Entry Into the IPV
timeFrame: 3-day post ablation
measure: Effectiveness: Technical Success
timeFrame: 15-day post ablation
measure: Effectiveness: Technical Success
timeFrame: 30-day post ablation
Secondary outcomes:
measure: Acute Ablation Success
timeFrame: 3-day post-procedure follow-up
measure: Acute Ablation Success
timeFrame: 15-day post-procedure
measure: Acute Ablation Success
timeFrame: 30-day post-procedure
measure: Reflux
timeFrame: 3-day post-procedure
measure: Reflux
timeFrame: 15-day post-procedure
measure: Reflux
timeFrame: 30-day post-procedure
Other outcomes:
Locations:
city: Tyler
country: United States
facility: Vein Center of East Texas at CardioStream
state: Texas
Study officials:
affiliation: Vein Center of East Texas at CardioStream
name: Jeffrey Carr, MD
role: PRINCIPAL_INVESTIGATOR
References: