Primary Chronic Venous Insufficiency Clinical Trial
Official title:
The Clinical Research of Surgery on Primary Chronic Venous Insufficiency
| NCT number | NCT00931424 |
| Other study ID # | 2008001 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | June 30, 2009 |
| Last updated | June 30, 2009 |
| Start date | January 2006 |
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | The first affiliated hospital of Sun Yat-Sen University | Guang Zhou | Guang dong |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Yat-sen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical-etiology-anatomic-pathophysiologic classification system | 3 month, 1 year, 3 year, 5 year, 7 year | No | |
| Secondary | phlebography | 3 month, 1 year, 3 year, 5 year, 7 year | No | |
| Secondary | color doppler | 3 month, 1 year, 3 year, 5 year, 7 year | No |