Compont - Varicose Veins of the Lower Extremities

Efficacy and Safety of Medical Adhesive in the Treatment of Varicose Veins of the Lower Extremities: A Prospective, Multicenter, Randomized Controlled Study

The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.

The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.

Participants will:

Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.

Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring.

Study Overview

• Status: Active, not recruiting
• Conditions: Varicose Veins of Lower Limb
• Intervention / Treatment: Device: Medical Adhesive; Device: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinically diagnosed as great saphenous vein varices. (This operation only dealt with one side varicose veins of the lower extremities.)
• CEAP is graded C2-C6.
• Doppler ultrasound confirmed the patency of deep veins of lower limbs.
• Sign informed consent, voluntarily participate in the trial and follow up as required

Exclusion Criteria:

• A history of lower extremity deep vein thrombosis or pulmonary embolism
• Recurrent varicose veins
• The diameter of target lesion of the great saphenous vein less than 2 mm or more than 15 mm
• The great saphenous vein is severely distorted or tuberculated at the root
• Sepsis or septicemia
• Allergic to n-butyl cyanoacrylate
• The distance between the skin and the target vessel wall of the great saphenous vein less than 5 mm
• Severe cardiopulmonary disease, shock, coma or multiple organ failure
• Lactating or pregnant women
• Participated in other clinical trials within 1 month before surgery
• The researchers considered it unsuitable for inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical Adhesive treatment group	Device: Medical Adhesive; Medical Adhesive (produced by Beijing Compont Medical Devices Co., Ltd.) For varicose veins in the main saphenous vein, use 0.1 ml glue for every 3 cm of blood vessels.
Active Comparator: Endovenous Radiofrequency Ablation Catheter	Device: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter; ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by America Medtronic Inc.) The ClosureFast catheter precisely heats a 7 cm vein segment in one 20-second interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate	At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.	24 weeks after operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Immediately after operation, Doppler ultrasound was used to check the closure of the target blood vessels.	Immediately after operation
Target vascular closure rate at 12 weeks after operation.	At 12 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.	12 weeks after operation.
Clinical signs	The severity of the patient's clinical presentation was assessed according to the Clinical signs- etiologic classification- anatomic distribution- pathophysiologic dysfunction classification (CEAP classification) criteria. classification are as follows. C0: Without any visible or palpable signs of disease. C1: Telangiectasia or reticular veins C2: Varicose veins C2r: Recurrent varicose veins C3: Edema is present. C4: Changes in skin and subcutaneous tissue C4a: Pigmentation or eczema C4b: Lipodermatosclerosis or atrophie blanche C4c: Corona phlebectatica C5: Healed ulcers C6: Active ulcers C6r: Recurrent active venous ulcer	Screening period, 12 and 24 weeks after operation.
Venous Clinical Severity Score (VCSS)	The VCSS score ranges from 0 to 30, with a larger value indicating approximately severe symptoms.	Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
Aberdeen Varicose Vein Questionnaire (AVVQ)	AVVQ scores range between 0 and 33, a higher score indicates a lower quality of life for patients.	Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
Operation duration		Immediately after operation
Evaluation of product performance	The researchers evaluated the operation performance of the product from the aspects of ease of operation and injection function, and divided the evaluation into three levels: satisfactory, general and unsatisfactory.	within 24 hours after operation

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University First Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Second Affiliated Hospital of Chongqing Medical University; Liaocheng People's Hospital; The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• Balint R, Farics A, Parti K, Vizsy L, Batorfi J, Menyhei G, Balint IB. Which endovenous ablation method does offer a better long-term technical success in the treatment of the incompetent great saphenous vein? Review. Vascular. 2016 Dec;24(6):649-657. doi: 10.1177/1708538116648035. Epub 2016 Apr 28.
• Dimech AP, Cassar K. Efficacy of Cyanoacrylate Glue Ablation of Primary Truncal Varicose Veins Compared to Existing Endovenous Techniques: A Systematic Review of the Literature. Surg J (N Y). 2020 Jun 19;6(2):e77-e86. doi: 10.1055/s-0040-1708866. eCollection 2020 Apr.
• Beteli CB, Rossi FH, de Almeida BL, Izukawa NM, Onofre Rossi CB, Gabriel SA, Kambara AM, de Moraes Rego Sousa AG, Thorpe P. Prospective, double-blind, randomized controlled trial comparing electrocoagulation and radiofrequency in the treatment of patients with great saphenous vein insufficiency and lower limb varicose veins. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):212-219. doi: 10.1016/j.jvsv.2017.09.010. Epub 2017 Dec 9.
• Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loftus IM. A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg. 2011 Dec;254(6):876-81. doi: 10.1097/SLA.0b013e318230af5a.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Varicose Veins of Lower Limb; NBCA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 2022PHC032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No