VenaSeal Sapheon Closure System Pivotal Study (VeClose)

NCT ID: NCT01807585

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-04-10

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

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 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.

Conditions

Great Saphenous Vein (GSV) With Venous Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VenaSeal SCS

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.

Group Type: EXPERIMENTAL

VenaSeal SCS

Intervention Type: DEVICE

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

RFA (ClosureFast)

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.

Group Type: ACTIVE_COMPARATOR

ClosureFast Radiofrequency Ablation (RFA)

Intervention Type: DEVICE

Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.

Roll-in (VenaSeal SCS)

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.

Group Type: EXPERIMENTAL

Roll-in (VenaSeal SCS)

Intervention Type: DEVICE

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Interventions

VenaSeal SCS

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Intervention Type: DEVICE

ClosureFast Radiofrequency Ablation (RFA)

Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.

Intervention Type: DEVICE

Roll-in (VenaSeal SCS)

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Intervention Type: DEVICE

Other Intervention Names

VenaSeal Sapheon Closure System; VSCS; ClosureFast; VenaSeal Sapheon Closure System; VSCS; Roll-in

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sapheon, Inc.

INDUSTRY

Sponsor Role: collaborator

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Morrison, MD

Role: PRINCIPAL_INVESTIGATOR

Morrison Vein Institute

Locations

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

Countries

United States

References

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. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.

Reference Type: RESULT

PMID: 28411697 (View on PubMed)

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. Epub 2016 Aug 8.

Reference Type: RESULT

PMID: 27638993 (View on PubMed)

Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613. doi: 10.1016/j.jvsv.2018.04.009. Epub 2018 Jun 15.

Reference Type: DERIVED

PMID: 29914814 (View on PubMed)

Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.

Reference Type: DERIVED

PMID: 25650040 (View on PubMed)

Other Identifiers

CP-11101-01

Identifier Type: -

Identifier Source: org_study_id