Clinical trial NCT00842296: ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
Official title: ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Reflux
Keywords: GSV
RadioFrequency
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Limbs Without Vein Occlusion
timeFrame: 6 Months
measure: Percentage of Limbs Without Vein Occlusion
timeFrame: 12 months
measure: Percentage of Limbs Without Vein Occlusion
timeFrame: 2 years
measure: Percentage of Limbs Without Vein Occlusion
timeFrame: 3 years
measure: Percentage of Limbs Without Vein Occlusion
timeFrame: 4 years
measure: Percentage of Limbs Without Vein Occlusion
timeFrame: 5 years
measure: Percentage of Limbs Without Reflux in the Treated Vein Segment
timeFrame: 6 months
measure: Percentage of Limbs Without Reflux in the Treated Vein Segment
timeFrame: 12 months
measure: Percentage of Limbs Without Reflux in the Treated Vein Segment
timeFrame: 2 years
measure: Percentage of Limbs Without Reflux in the Treated Vein Segment
timeFrame: 3 years
measure: Percentage of Limbs Without Reflux in the Treated Vein Segment
timeFrame: 4 years
measure: Percentage of Limbs Without Reflux in the Treated Vein Segment
timeFrame: 5 years
Secondary outcomes:
measure: CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification
timeFrame: Baseline
measure: CEAP Classification
timeFrame: 1 Week
measure: CEAP Classification
timeFrame: 3 months
measure: CEAP Classification
timeFrame: 12 months
measure: CEAP Classification
timeFrame: 5 years
measure: Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up
timeFrame: Baseline thru 5 years
measure: Visual Analog Pain Scale (VAS)
timeFrame: 5 years
measure: Presence of Complications From Greater Saphenous Vein (GSV) Intervention
timeFrame: 1 Week
measure: Presence of Complications From GSV Intervention
timeFrame: 3 Months
measure: Presence of Complications From GSV Intervention
timeFrame: 12 months
measure: Presence of Complications From GSV Intervention
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Medtronic
name: Melissa Hasenbank, PhD
role: STUDY_DIRECTOR
References:
citation: 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.