VenaSeal Sapheon Closure System Pivotal Study (VeClose) — VeClose  

Great Saphenous Vein (GSV) With Venous Reflux Disease Clinical Trial

Official title: VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins

Status Completed

Clinical Trial 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.

Clinical Trial Description

The purpose of the VeClose study was to demonstrate safety and effectiveness of the VenaSeal SCS as being both 1) non-inferior to RFA therapy in achieving anatomical closure of lower extremity superficial truncal veins in patients with venous reflux through endovascular transcatheter embolization with coaptation of the GSV at 3 months, and 2) superior in the reduction of intraprocedural and post procedural pain and symptoms as compared to treatment with RFA.

The study was designed to demonstrate safety of the VenaSeal SCS by follow-up visits that evaluated, via duplex ultrasound and physical exam, the presence of deep vein thrombosis and/or pulmonary embolus. ;

Related Conditions & MeSH terms

• Great Saphenous Vein (GSV) With Venous Reflux Disease

• NCT number: NCT01807585
• Study type: Interventional
• Source: Medtronic Endovascular
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Completion date: April 10, 2017