VenaSeal Sapheon Closure System Pivotal Study (VeClose)

Great Saphenous Vein (GSV) With Venous Reflux Disease Clinical Trial

— VeClose  

Official title:

VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807585
• Other study ID #: CP-11101-01
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: April 10, 2017

Study information

• Verified date: May 2018
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: April 10, 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Great Saphenous Vein (GSV) With Venous Reflux Disease

Intervention

Device:
• VenaSeal SCS
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
• ClosureFast Radiofrequency Ablation (RFA)
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
• Roll-in (VenaSeal SCS)
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Endovascular	Sapheon, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kolluri R, Gibson K, Cher D, Madsen M, Weiss R, Morrison N. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. — View Citation

Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Closure of the Target Vein at 3 Months	The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.	3 months
Secondary	Intraoperative Pain	After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.	During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group.
Secondary	Ecchymosis at Day 3	At the Day 3 visit, the investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis Assessment with a 0-5 rating scale, with 0 being the best possible outcome and 5 being the worst possible outcome.; The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site.; The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria: 0 rating = no ecchymosis,; rating = less than 25% ecchymosis,; rating = 25-50% ecchymosis,; rating = 50-75% ecchymosis,; rating = 75-100% ecchymosis,; rating = extension of ecchymosis above or below the treated area.	First follow up visit at day 3