Varicose Veins of Lower Limb
Conditions
Keywords
Varicose Veins of Lower Limb, NBCA
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.
Interventions
DEVICEMedical 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.
DEVICEClosureFast 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.
Sponsors
Peking University First Hospital
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
First Affiliated Hospital Xi'an Jiaotong University
Liaocheng People's Hospital
The Second Affiliated Hospital of Chongqing Medical University
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate | 24 weeks after operation. | At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target vascular closure rate at 12 weeks after operation. | 12 weeks after operation. | At 12 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels. |
| Clinical signs | Screening period, 12 and 24 weeks after operation. | 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 |
| Venous Clinical Severity Score (VCSS) | Screening period, 4 weeks, 12 weeks and 24 weeks after operation. | The VCSS score ranges from 0 to 30, with a larger value indicating approximately severe symptoms. |
| Technical success rate | Immediately after operation | Immediately after operation, Doppler ultrasound was used to check the closure of the target blood vessels. |
| Operation duration | Immediately after operation | — |
| Evaluation of product performance | within 24 hours after operation | 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. |
| Aberdeen Varicose Vein Questionnaire (AVVQ) | Screening period, 4 weeks, 12 weeks and 24 weeks after operation. | AVVQ scores range between 0 and 33, a higher score indicates a lower quality of life for patients. |
Countries
China
Outcome results
None listed