VeClose Five Year Follow-Up Extension Study

Medtronic

Status: Completed

Conditions: Great Saphenous Vein (GSV) With Venous Reflux Disease

Treatments: Device: Roll-In (VenaSeal SCS); Device: VenaSeal SCS; Device: ClosureFast Radiofrequency Ablation (RFA)

Study type: Observational

Funder types: Industry

Identifiers

NCT03455699

CP-1011

Details and patient eligibility

About

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).

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Enrolled in the VeClose study.
2. Able and willing to complete the required 5 year study visit including Duplex ultrasound exam.
3. Able and willing to provide written informed consent prior to study specific data collection.

Exclusion criteria

1. Withdrew consent from the VeClose study.

Trial design

114 participants in 3 patient groups

Experimental: VenaSeal SCS

Description:

Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA at the time of enrollment into the VeClose study (NCT01807585).

Treatment:

Device: VenaSeal SCS

Active Comparator: RFA

Description:

Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Heat is applied to the target vein using radiofrequency energy to ablate the target vein. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA at the time of enrollment into the VeClose study (NCT01807585).

Treatment:

Device: ClosureFast Radiofrequency Ablation (RFA)

Experimental: Roll-in (VenaSeal SCS)

Description:

Prior to initiation of the randomized cohort at each site for the VeClose study (NCT01807585), a non-randomized cohort of 2 subjects per site (roll-in phase) were enrolled and treated with VenaSeal SCS with endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc.

Treatment:

Device: Roll-In (VenaSeal SCS)