Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins

Chronic Venous Insufficiency Clinical Trial

— CASS  

Official title:

Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03835559
• Other study ID #: 2018-03-030-001
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2019
• Source: Kyung Hee University Hospital at Gangdong
• Contact: Jin Hyun Joh, MD, PhD
• Phone: +82-2-440-6261
• Email: vascularjoh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.

Description:

Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: February 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 80 years of age at the time of enrollment

• Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position

• Diameter of saphenous vein between 2mm to 20mm (with standing position)

• One or more of the following symptoms related to the incompetent saphenous vein:

aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling

• Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5

Exclusion Criteria:

• Previous treatment in targeted vein segment

• Tortuous vein in which the delivery catheter cannot be inserted

• Aneurysm of target vein segment >20 mm

• Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux

• Known hypercoagulable disorder

• Active malignancy

• Regular use of systemic anticoagulation

• Current use of systemic anticoagulant

• Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis

• Unable to comply with the schedule and protocol evaluations

• Unable to ambulate

• Currently pregnant or breast feeding

• Known sensitivity to cyanoacrylate adhesives

• Symptomatic peripheral arterial disease with ankle-brachial index <0.9

• Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment

• Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Occlusions Vein
• Venous Insufficiency

Intervention

Procedure:
• Cyanoacrylate closure
After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.
• Surgical stripping
All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.

Locations

Country	Name	City	State
Korea, Republic of	In-Mok Jung	Seoul	Non US/Canada
Korea, Republic of	Jin Hyun Joh	Seoul	Non US/Canada

Sponsors (1)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Chan YC, Law Y, Cheung GC, Ting AC, Cheng SW. Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome. Phlebology. 2017 Mar;32(2):99-106. doi: 10.1177/0268355516638200. Epub 2016 Jul 9. — View Citation

Kaplan RM, Criqui MH, Denenberg JO, Bergan J, Fronek A. Quality of life in patients with chronic venous disease: San Diego population study. J Vasc Surg. 2003 May;37(5):1047-53. — View Citation

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, 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: 10.10 — View Citation

van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure rate of the target vein/ Absence of refluxing vein	The primary endpoint of the study is to evaluate the complete closure of the target vein where complete closure is defined as Doppler ultrasound showing vein closure along entire treated vein segment with no discrete segments of patency exceeding 5cm after cyanoacrylate closure and absence of refluxing vein or residual vein after surgical stripping as read by a qualified site technologist or investigator.	3 months
Secondary	Perioperative pain with visual analog scale	The subject will be asked to rate pain on a 0-10 numeric rating scale. (minimum-0 (best), maximum-10 (worst))	3 days
Secondary	Ecchymosis	The investigator will score the subjects ipsilateral leg of the occurrence of ecchymosis along treated segment, rated on a 0- to 5-point graded scale (0, none; 1, involving <25% of the treatment area; 2, 25%-50%; 3, 50%-75%; 4, 75%-100%; 5, extension above or below the treatment segment)	3 days
Secondary	Venous Clinical Severity Score	Severity score on a 0-30 numeric rating scale ((minimum-0 (best), maximum-30 (worst))	1, 3, 6, 12 and 24 months after treatment
Secondary	Acceptability of Quality of life score	The quality of life scores are measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) and EuroQOL five dimensions questionnaire (EQ-5D).; The AVVQs are scored using a questionnaire. The total score for the 13 questions ranges from 0 to 100 points, with 0 points indicating the best possible quality of life. The EuroQOL is an instrument which evaluates the generic quality of life. The EuroQOL descriptive system is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).	1, 3, 6, 12 and 24 months after treatment
Secondary	Satisfaction of the patients: satisfaction rate	The subject will be asked to the satisfaction rate by five response categories (strongly agree, agree, uncertain, disagree, strongly disagree) after asking as following: I'm very satisfied with the medical care I receive.	1, 3, 6, 12 and 24 months after treatment