VenaSeal Sapheon Closure System Pivotal Study (VeClose)

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT01807585

Run by

Medtronic Endovascular

People needed

242

Starts

2013-03-01

Expected to finish

2017-04-10

Last updated by the study team

2018-06-26

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Morrison Vein Institute — Scottsdale, Arizona, United States
• GBK Cosmetic Laser Dermatology — San Diego, California, United States
• Radiology Imaging Associates (RIA) — Greenwood Village, Colorado, United States
• Vein Clinics of America — Oakbrook Terrace, Illinois, United States
• Prairie Education & Research Cooperative — Springfield, Illinois, United States
• MD Laser Skin & Vein Institute — Hunt Valley, Maryland, United States
• Vein Institute of Buffalo — North Tonawanda, New York, United States
• Inovia Vein Specialty Center — Bend, Oregon, United States
• Sentara Vascular Specialist — Virginia Beach, Virginia, United States
• Lake Washington Vascular — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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