Phase 4
N=69
ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.
Venous Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00509392 ↗Enrolled (actual)
69
Serious AEs
1.2%
Results posted
Jul 2017
Primary outcome: Primary: Pain — 0.7; 1.9 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Seg. RF Ablation & ClosureFAST catheter (Device); Endovenous Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
0.2; 0.4 | 0.2962 |
| PRIMARY Pain |
0.2; 0.4 | 0.2962 |
| PRIMARY Pain |
0.2; 0.4 | 0.2962 |
| PRIMARY Pain |
0.2; 0.4 | 0.2962 |
| PRIMARY Tenderness |
0.3; 0.5 | 0.5761 |
| PRIMARY Tenderness |
0.3; 0.5 | 0.5761 |
| PRIMARY Tenderness |
0.3; 0.5 | 0.5761 |
| PRIMARY Tenderness |
0.3; 0.5 | 0.5761 |
| PRIMARY Ecchymosis |
45; 31; 1; 9; 0; 0 | 0.0050 sig |
| PRIMARY Ecchymosis |
45; 31; 1; 9; 0; 0 | 0.0050 sig |
| PRIMARY Ecchymosis |
45; 31; 1; 9; 0; 0 | 0.0050 sig |
| PRIMARY Ecchymosis |
45; 31; 1; 9; 0; 0 | 0.0050 sig |
| PRIMARY Complications |
1; 0; 0; 8; 2; 3 | — |
| SECONDARY VCSS |
2.7; 3.2 | 0.2825 |
| SECONDARY VCSS |
2.7; 3.2 | 0.2825 |
| SECONDARY VCSS |
2.7; 3.2 | 0.2825 |
| SECONDARY VCSS |
2.7; 3.2 | 0.2825 |
| SECONDARY Change in CIVIQ QOL |
-17.8; -17.5 | 0.9463 |
| SECONDARY Change in CIVIQ QOL |
-17.8; -17.5 | 0.9463 |
| SECONDARY Change in CIVIQ QOL |
-17.8; -17.5 | 0.9463 |
| SECONDARY Change in CIVIQ QOL |
-17.8; -17.5 | 0.9463 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00509392). 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.