VenaSeal Sapheon Closure System Pivotal Study (VeClose)

Medtronic

Status: Completed

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01807585

CP-11101-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 21 years and ≤ 70 years of age at the time of screening
2. Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux
3. 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
4. GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound
5. Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b
6. Ability to walk unassisted
7. Ability to attend follow-up visits
8. Ability to understand the requirements of the study and to provide informed consent

Exclusion criteria

1. Life expectancy < 1 year
2. Active treatment for malignancy other than non-melanoma skin cancer
3. Symptomatic peripheral arterial disease with ankle-brachial index (ABI) <0.89
4. Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux
5. Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
6. Previous or suspected deep vein thrombosis (DVT) or pulmonary embolus (PE)
7. Previous superficial thrombophlebitis in GSV
8. Previous treatment of venous disease in target limb, other than spider vein treatment
9. Known hypercoagulable disorder
10. Conditions which prevent vein treatment with either RFA or VenaSeal SCS
11. Immobilization or inability to ambulate
12. Pregnant prior to enrollment
13. Tortuous GSV, which, in the opinion of the investigator, will limit catheter placement or require more than one primary access site
14. Aneurysm of the target vein with local diameter >12 mm
15. Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s)
16. Known sensitivity to cyanoacrylate (CA) adhesives
17. Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment
18. Patients who require bilateral treatment during the next 3 months
19. Patients who require additional ipsilateral treatments on the same leg within 3 months following treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 3 patient groups

VenaSeal SCS

Experimental group

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.

Treatment:

Device: VenaSeal SCS

RFA (ClosureFast)

Active Comparator group

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 RFA.

Treatment:

Device: ClosureFast Radiofrequency Ablation (RFA)

Roll-in (VenaSeal SCS)

Experimental group

Description:

Prior to initiation of the randomized cohort at each site, a non-randomized cohort of 2 subjects per clinical site (roll-in phase) were enrolled and treated with VenalSeal 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)