NCT01807585

VenaSeal Sapheon Closure System Pivotal Study (VeClose)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Great Saphenous Vein (GSV) With Venous Reflux Disease

Interventions

Type	Name	Description
DEVICE	VenaSeal SCS	Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
DEVICE	ClosureFast Radiofrequency Ablation (RFA)	Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
DEVICE	Roll-in (VenaSeal SCS)	Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-12-01
• Completion: 2017-04-10
• First posted: 2013-03-08
• Last updated: 2018-06-26
• Results posted: 2018-06-26

Locations

10 sites across 1 country: United States