Status:
COMPLETED
VenaSeal Sapheon Closure System Pivotal Study (VeClose)
Lead Sponsor:
Medtronic Endovascular
Collaborating Sponsors:
Sapheon, Inc.
Conditions:
Great Saphenous Vein (GSV) With Venous Reflux Disease
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief 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 Vena...
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 superfi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2017
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT01807585
Start Date
March 1 2013
End Date
April 10 2017
Last Update
June 26 2018
Active Locations (10)
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1
Morrison Vein Institute
Scottsdale, Arizona, United States, 85255
2
GBK Cosmetic Laser Dermatology
San Diego, California, United States, 92121
3
Radiology Imaging Associates (RIA)
Greenwood Village, Colorado, United States, 80111
4
Vein Clinics of America
Oakbrook Terrace, Illinois, United States, 60181