ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters.

Study Overview

• Status: Completed
• Conditions: Venous Reflux
• Intervention / Treatment: Device: RF ablation (ClosureFAST)

Detailed Description

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 80 years of age at the time of enrollment
• Symptomatic lower limb venous disease involving the GSV

Exclusion Criteria:

• Thrombosis in the vein segment to be treated
• Known or suspected pregnancy or actively breast feeding at time of treatment

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: Seg. RF Ablation with CLF catheter; Single Arm with CLF Catheter	Device: RF ablation (ClosureFAST); Segmental RF Ablation with the CLF catheter; Other Names: CLF; CLosureFAST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Limbs Without Vein Occlusion	Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures < 3 cm in length, does not constitute a failure.	6 Months
Percentage of Limbs Without Vein Occlusion	Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.	12 months
Percentage of Limbs Without Vein Occlusion	Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan.	2 years
Percentage of Limbs Without Vein Occlusion	Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.	3 years
Percentage of Limbs Without Vein Occlusion	Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.	4 years
Percentage of Limbs Without Vein Occlusion	Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.	5 years
Percentage of Limbs Without Reflux in the Treated Vein Segment	No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.	6 months
Percentage of Limbs Without Reflux in the Treated Vein Segment	No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.	12 months
Percentage of Limbs Without Reflux in the Treated Vein Segment	No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.	2 years
Percentage of Limbs Without Reflux in the Treated Vein Segment	No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.	3 years
Percentage of Limbs Without Reflux in the Treated Vein Segment	No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.	4 years
Percentage of Limbs Without Reflux in the Treated Vein Segment	No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification	Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at baseline. The CEAP clinical Categories are as follows where C1 is of the least clinical concern and C6 is the worst stage; C1- Reticular and spider veins C2- Varicose veins C3- Varicose veins and leg swelling C4- Varicose veins and evidence of venous stasis skin changes C5- Varicose veins and a healed venous stasis ulceration C6- Varicose veins and an open venous ulceration Reference: Kistner RL, Eklof B, Masuda EM. Diagnosis of chronic venous disease of the lower extremities: The "CEAP" classification. Mayo Clinic Proc 1996;71:338-45.	Baseline
CEAP Classification	Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.	1 Week
CEAP Classification	Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.	3 months
CEAP Classification	Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.	12 months
CEAP Classification	Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.	5 years
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up	Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VCSS Status from Baseline to 5 years. VCSS assesses 10 factors of venous disease whereby each factor is graded on a severity scale of 0-3 (least to worst). The higher the VCSS score the most severe the clinical signs and symptoms of venous disease are in a patient. VCSS improvement over time is presented by a decrease in VCSS total score (maximum score = 30; minimum score = 0). Reference: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg 2000;31:1307-12.	Baseline thru 5 years
Visual Analog Pain Scale (VAS)	Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VAS for pain scored from 0-10 with 10 being worst possible pain	5 years
Presence of Complications From Greater Saphenous Vein (GSV) Intervention	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.	1 Week
Presence of Complications From GSV Intervention	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.	3 Months
Presence of Complications From GSV Intervention	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.	12 months
Presence of Complications From GSV Intervention	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.	5 years

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Study Director: Melissa Hasenbank, PhD, Medtronic

Publications and helpful links

General Publications

• Proebstle TM, Mohler T. A longitudinal single-center cohort study on the prevalence and risk of accessory saphenous vein reflux after radiofrequency segmental thermal ablation of great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):265-9. doi: 10.1016/j.jvsv.2014.10.001. Epub 2014 Dec 6.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 10, 2009
• First Submitted That Met QC Criteria: February 11, 2009
• First Posted (Estimate): February 12, 2009

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: RadioFrequency; GSV
• Other Study ID Numbers: CLF-05-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES