Incompetent Perforating Veins Clinical Trial
— PESIVOfficial title:
Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins : A Multi-center Prospective Randomized Controlled Trial
This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.
| Status | Recruiting |
| Enrollment | 84 |
| Est. completion date | December 30, 2025 |
| Est. primary completion date | December 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: (1) outward flow of less than 500 ms duration, with a diameter of >3.5 mm; (2) According to the CEAP classification method specified by the International Venous Federation, patients with C4b~C6 grades are included. Exclusion Criteria: (1)age < 18 years or age > 80 years; (2)with malignant tumors and life expectancy < 1 year; (3)with past or current history of deep vein thrombosis and/or pulmonary embolism in the lower extremities; (4)with congenital venous malformations (K-T syndrome, arteriovenous fistula and etc.; (5)inability to walk, long-term braking, restrictive bed rest; severe ischemia of lower extremities or diagnosed severity of peripheral artery occlusive disease; (6)according to the researcher's judgment, it is not suitable for foam hardener and puncture coagulation treatment; (7)allergic to the drugs and equipment materials involved in the research; (8)with inferior vena cava and/or iliac vein stenosis or occlusion; (9)with autoimmune disease, receiving chemotherapy, hormone therapy or immunomodulatory treatment; (10)other underlying severe diseases; women who are pregnant, breastfeeding or have pregnancy plans during the study period; (11)the patient cannot cooperate to complete the inspection and follow-up required by the study. |
| Country | Name | City | State |
|---|---|---|---|
| China | Sir Run Run Shaw Hospital | Hangzhou | Zhejiang |
| China | The second affiliated hospital of zhejiang university school of medicine | Hangzhou | Zhejiang |
| China | Anhui Provincial Hospital | Hefei | Anhui |
| China | Zhongshan Hospital affiliated to Fudan University | Shanghai | Shanghai |
| China | Yantai Yuhuangding Hospital | Yantai | Shandong |
| Lead Sponsor | Collaborator |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Anhui Provincial Hospital, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, Yantai Yuhuangding Hospital |
China,
Cooper DG, Hillman-Cooper CS, Barker SG, Hollingsworth SJ. Primary varicose veins: the sapheno-femoral junction, distribution of varicosities and patterns of incompetence. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):53-9. doi: 10.1053/ejvs.2002.1782. — View Citation
Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079. — View Citation
Guex JJ. Ultrasound guided sclerotherapy (USGS) for perforating veins (PV). Hawaii Med J. 2000 Jun;59(6):261-2. No abstract available. — View Citation
Hager ES, Washington C, Steinmetz A, Wu T, Singh M, Dillavou E. Factors that influence perforator vein closure rates using radiofrequency ablation, laser ablation, or foam sclerotherapy. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):51-6. doi: 10.1016/j.jvsv.2015.08.004. — View Citation
Masuda EM, Kessler DM, Lurie F, Puggioni A, Kistner RL, Eklof B. The effect of ultrasound-guided sclerotherapy of incompetent perforator veins on venous clinical severity and disability scores. J Vasc Surg. 2006 Mar;43(3):551-6; discussion 556-7. doi: 10.1016/j.jvs.2005.11.038. — View Citation
Sakurai T, Matsushita M, Nishikimi N, Nimura Y. Hemodynamic assessment of femoropopliteal venous reflux in patients with primary varicose veins. J Vasc Surg. 1997 Aug;26(2):260-4. doi: 10.1016/s0741-5214(97)70187-3. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | IPVs occlusion rate in the 12th month. | IPVs occlusion rate is defined as DS > 50% for each modality with no procedure no procedure performed on the treated segment | 12 months after operation | |
| Secondary | Quality of life scale survey results | quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score).Quality of life will be assessed by MOS item short-form health survey scale (SF-36). SF-36 includes eight subscales: physical functioning (PF, 10 items), role limitations due to physical health problems (RL-P, 4 items), bodily pain (BP, 2 items), general health (GH, 5 items), vitality (V, 4 items), social functioning (SF, 2 items), role limitations due to emotional problems (RL-E, 3 items) and mental health (MH, 5 items). The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best). | 1-month,6-month,12-month | |
| Secondary | Skin ulcer recurrence rate | Skin ulcer recurrence | 1-month,6-month,12-month | |
| Secondary | Proportion of participants with deep venous Thrombosis | deep venous Thrombosis | 1-month,6-month,12-month | |
| Secondary | Proportion of participants with hemorrhage | Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding | 1-month,6-month,12-month | |
| Secondary | All-cause mortality and other vascular events and serious complications. | Percentage of participants with all deaths | 1-month,6-month,12-month |