Clinical trial NCT06387264: Compont - Varicose Veins of the Lower Extremities
Official title: Efficacy and Safety of Medical Adhesive in the Treatment of Varicose Veins of the Lower Extremities: A Prospective, Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Varicose Veins of Lower Limb
Keywords: Varicose Veins of Lower Limb
NBCA
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: First Affiliated Hospital Xi'an Jiaotong University
name: Liaocheng People's Hospital
name: The Second Affiliated Hospital of Chongqing Medical University
First posted: 2024-04-29
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical success rate
timeFrame: 24 weeks after operation.
Secondary outcomes:
measure: Technical success rate
timeFrame: Immediately after operation
measure: Target vascular closure rate at 12 weeks after operation.
timeFrame: 12 weeks after operation.
measure: Clinical signs
timeFrame: Screening period, 12 and 24 weeks after operation.
measure: Venous Clinical Severity Score (VCSS)
timeFrame: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
measure: Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
measure: Operation duration
timeFrame: Immediately after operation
measure: Evaluation of product performance
timeFrame: within 24 hours after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References:
citation: 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.
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: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
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. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.
citation: 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.
citation: 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.
citation: 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.