NCT03455699

VeClose Five Year Follow-Up Extension Study

Follow-up of Patients Treated in VeClose Study (Five Years)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 114 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).

Detailed description

The VeClose Five Year Follow-up Extension Study will continue to assess the safety and efficacy of the VenaSeal Closure System for the long term effect on closure of the great saphenous vein by conducting a follow-up visit at five years post index procedure/enrollment in the VeClose study.

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: 2016-07-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2018-03-06
• Last updated: 2019-04-12

Locations

9 sites across 1 country: United States