N/A
Completed N=326
ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
Venous Reflux
Source: ClinicalTrials.gov NCT00842296 ↗
Enrolled (actual)
326
Serious AEs
3.1%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Limbs Without Vein Occlusion — 97.6 percentage of limbs
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Limbs Without Vein Occlusion |
90.0 | — |
| 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 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 | — |
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
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. Informational only — not medical advice.