N/A N=326 Treatment

ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

Venous Reflux

Bottom Line

View on ClinicalTrials.gov: NCT00842296 ↗

Enrolled (actual)

326

Serious AEs

3.1%

Results posted

Dec 2017

Primary outcome: Primary: Percentage of Limbs Without Vein Occlusion — 97.6 percentage of limbs

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: RF ablation (ClosureFAST) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Endovascular
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Limbs Without Vein Occlusion	90.0	—
PRIMARY Percentage of Limbs Without Vein Occlusion	90.0	—
PRIMARY Percentage of Limbs Without Vein Occlusion	90.0	—
PRIMARY Percentage of Limbs Without Vein Occlusion	90.0	—
PRIMARY Percentage of Limbs Without Vein Occlusion	90.0	—
PRIMARY Percentage of Limbs Without Vein Occlusion	90.0	—
PRIMARY Percentage of Limbs Without Reflux in the Treated Vein Segment	93.7	—
PRIMARY Percentage of Limbs Without Reflux in the Treated Vein Segment	93.7	—
PRIMARY Percentage of Limbs Without Reflux in the Treated Vein Segment	93.7	—
PRIMARY Percentage of Limbs Without Reflux in the Treated Vein Segment	93.7	—
PRIMARY Percentage of Limbs Without Reflux in the Treated Vein Segment	93.7	—
PRIMARY Percentage of Limbs Without Reflux in the Treated Vein Segment	93.7	—
SECONDARY CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification	1; 5; 213; 110; 60; 4	—
SECONDARY CEAP Classification	22; 116; 101; 26; 12; 2	—
SECONDARY CEAP Classification	22; 116; 101; 26; 12; 2	—
SECONDARY CEAP Classification	22; 116; 101; 26; 12; 2	—
SECONDARY CEAP Classification	22; 116; 101; 26; 12; 2	—
SECONDARY Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up	4.4; 4.1; 1.3; 1.0; 0.9; 0.9	—
SECONDARY Visual Analog Pain Scale (VAS)	1.2; 0.4; 0.2; 0.2; 0.2; 0.2	—
SECONDARY Presence of Complications From Greater Saphenous Vein (GSV) Intervention	23; 5; 4; 0; 7; 6	—
SECONDARY Presence of Complications From GSV Intervention	0; 0; 0; 0; 1; 2	—
SECONDARY Presence of Complications From GSV Intervention	0; 0; 0; 0; 1; 2	—
SECONDARY Presence of Complications From GSV Intervention	0; 0; 0; 0; 1; 2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00842296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.