N/A
Completed N=242
VenaSeal Sapheon Closure System Pivotal Study (VeClose)
Great Saphenous Vein (GSV) With Venous Reflux Disease
Source: ClinicalTrials.gov NCT01807585 ↗
Enrolled (actual)
242
Serious AEs
5.0%
Results posted
Jun 2018
Primary outcomePrimary: Number of Participants With Complete Closure of the Target Vein at 3 Months — 107; 109 Participants — p=<0.0001
Summary
The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Closure of the Target Vein at 3 Months |
107; 109 | <0.0001 sig |
| SECONDARY Intraoperative Pain |
1.28; 2.16; 2.35 | — |
| SECONDARY Ecchymosis at Day 3 |
15; 73; 55; 5; 29; 38 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 21 years and ≤ 70 years of age at the time of screening
- Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux
- One or more of the following symptoms related to the target vein: aching, throbbing, heaviness, fatigue, pruritis, night cramps, restlessness, generalized pain or discomfort, swelling
- GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound
- Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b
- Ability to walk unassisted
- Ability to attend follow-up visits
- Ability to understand the requirements of the study and to provide informed consent
Exclusion Criteria
- Life expectancy 12 mm
- Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s)
- Known sensitivity to cyanoacrylate (CA) adhesives
- Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment
- Patients who require bilateral treatment during the next 3 months
- Patients who require additional ipsilateral treatments on the same leg within 3 months following treatment
Data sourced from ClinicalTrials.gov (NCT01807585). 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.