ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.

Medtronic Endovascular69 enrolled

Overview

The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.

Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Venous Reflux

Interventions

Seg. RF Ablation & ClosureFAST catheterDEVICE

Seg. RF Ablation \& ClosureFAST catheter

Endovenous LaserDEVICE

laser catheter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All subjects must provide written informed consent. * Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser. Exclusion Criteria: * Subjects who require additional treatments in either leg within 30 days before or after the study procedure. * Subjects who are participating in another investigational study.

Locations (1)

Oregon Health Sciences

Portland, Oregon, United States

Outcomes

Primary Outcomes

Pain

Pain 0-10 scale (10 most severe)

Time frame: 48 Hour

Pain

Pain 0-10 scale (10 most severe)

Time frame: 1 Week

Pain

Pain 0-10 scale (10 most severe)

Time frame: 2 Weeks

Pain

Pain 0-10 scale (10 most severe)

Time frame: 1 Month

Tenderness

Tenderness 0-10 scale (10 most severe)

Time frame: 48 Hour

Tenderness

Tenderness 0-10 scale (10 most severe)

Time frame: 1 Week

Tenderness

Tenderness 0-10 scale (10 most severe)

Time frame: 2 Weeks

Tenderness

Tenderness 0-10 scale (10 most severe)

Time frame: 1 Month

Ecchymosis

0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below treated (tx) segment

Time frame: 48 Hours post treatment (no baseline)

Ecchymosis

0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment

Time frame: 1 Week post treatment (no baseline)

Data from ClinicalTrials.gov

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Secondary Outcomes

VCSS

Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Time frame: 48 Hours

VCSS

Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Time frame: 1 Week

VCSS

Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Time frame: 2 Weeks

VCSS

Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Time frame: 1 Month

Change in CIVIQ QOL

Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline

Time frame: 48 Hours

Change in CIVIQ QOL

Time frame: 1 Week

Change in CIVIQ QOL

Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline

Time frame: 2 Week

Change in CIVIQ QOL

Time frame: 1 Month