The Clinical Trial for Primary Chronic Venous Insufficiency
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency...
Brief Summary
Official Title: “The Clinical Research of Surgery on Primary Chronic Venous Insufficiency”
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2015
Intervention(s) in this Clinical Trial
- Procedure: valve reconstruction
- reconstruct valve at the same time of superficial vein surgery
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: reconstruction
- patients in this group will have both valve reconstruction and superficial vein surgery
- No Intervention: unreconstruction
- patients in this group will only have superficial vein surgery
Outcome Measures for this Clinical Trial
Primary Measures
- clinical-etiology-anatomic-pathophysiologic classification system
- Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year
Safety Issue?: No
- Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year
Secondary Measures
- phlebography
- Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year
Safety Issue?: No
- Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year
- color doppler
- Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year
Safety Issue?: No
- Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- PCVI patients with III degree back flow in deep vein that is confirmed by color doppler or phlebography
Exclusion Criteria:
- age over 70 years old
- pregnancy
- patients with severity arteriosclerosis obliterans, malignancy, severity disease of heart, lung or brain, and hematopathy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 15 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sun Yat-sen University Other
Overall Clinical Trial Officials and Contacts
Shen-ming Wang, doctor Study Chair First Affiliated Hospital, Sun Yat-Sen University
Overall Contact: Shen-ming Wang, Professor +86 020 87755766－8198 shenmingwang@sohu.com
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931424
Study ID Number: 2008001
ClinicalTrials.gov Identifier: NCT00931424
Health Authority: China:Ministry of Health of People's Republic of China
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00931424
