Compont - Varicose Veins of the Lower Extremities

NCT06387264 | Active Not Recruiting

• 1 other identifier: 2022PHC032
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins of Lower Limb

Keywords

Varicose Veins of Lower Limb; NBCA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Technical success rate

  Immediately after operation

• Target vascular closure rate at 12 weeks after operation.

  12 weeks after operation.

• Clinical signs

  Screening period, 12 and 24 weeks after operation.

• Venous Clinical Severity Score (VCSS)

  Screening period, 4 weeks, 12 weeks and 24 weeks after operation.

• Aberdeen Varicose Vein Questionnaire (AVVQ)

  Screening period, 4 weeks, 12 weeks and 24 weeks after operation.

Study Arms (2)

Medical Adhesive treatment group

EXPERIMENTAL

Device: Medical Adhesive

Endovenous Radiofrequency Ablation Catheter

ACTIVE COMPARATOR

Device: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter

Interventions

Medical Adhesive DEVICE

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.

Medical Adhesive treatment group

ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter DEVICE

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.

Endovenous Radiofrequency Ablation Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

Related Publications (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.

  PMID: 27126643 BACKGROUND

• 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.

  PMID: 25650040 BACKGROUND

• 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.

  PMID: 28411697 BACKGROUND

• 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.

  PMID: 32577526 BACKGROUND

• 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.

  PMID: 29229466 BACKGROUND

• 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.

  PMID: 21934487 BACKGROUND

MeSH Terms

Interventions

Catheters

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Vascular Surgery

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 29, 2024
• Study Start: January 11, 2023
• Primary Completion: April 3, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)