Overview

This trial is active, not recruiting.

Condition great saphenous vein (gsv) with venous reflux disease
Treatments venaseal sapheon closure system (vscs), closurefast radiofrequency ablation (rfa)
Phase phase 2
Sponsor Sapheon, Inc.
Start date March 2013
End date December 2013
Trial size 244 participants
Trial identifier NCT01807585, CP-11101-01

Summary

This is a randomized control trial comparing VenaSeal Sapheon Closure System with Radiofrequency Ablation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Designed to facilitate embolization with coaptation of lower extremity veins, including the GSV, in patients with venous reflux disease.
venaseal sapheon closure system (vscs)
(Active Comparator)
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system
closurefast radiofrequency ablation (rfa)

Primary Outcomes

Measure
Complete closure of the target vein
time frame: 3 months

Secondary Outcomes

Measure
Intraoperative pain
time frame: During the procedure
Ecchymosis at Day 3
time frame: First follow up visit at day 3

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

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. 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 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 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. -

Additional Information

Official title Randomized Control Trial Comparing VenaSeal Sapheon Closure System With Radiofrequency Ablation
Principal investigator Nick Morrison, MD
Description To demonstrate safety and effectiveness of the VenaSeal SCS as being both non-inferior to RF ablation therapy in achieving anatomical closure of lower extremity superficial truncal veins in patients with venous reflux through endovascular transcatheter embolization with coaptation of the great saphenous vein (GSV) and in the reduction of intraprocedural and post procedural pain and symptoms. The study will demonstrate safety of the VenaSeal SCS by follow-up visits that will evaluate via duplex ultrasound and physical exam the presence of deep vein thrombosis and or pulmonary embolus.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Sapheon, Inc..