The Clinical Trial for Primary Chronic Venous Insufficiency

Not Applicable

• Conditions: Primary Chronic Venous Insufficiency
• Interventions: Procedure: valve reconstruction

• Registration Number: NCT00931424
• Lead Sponsor: Sun Yat-sen University

Brief Summary

A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Status Verified: 2009-05
• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-06-30
• Last Update Submitted: 2009-06-30
• Study First Posted: 2009-07-02
• Last Update Posted: 2009-07-02
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
reconstruction	valve reconstruction	patients in this group will have both valve reconstruction and superficial vein surgery

Primary Outcome Measures

Name	Time	Method
clinical-etiology-anatomic-pathophysiologic classification system	3 month, 1 year, 3 year, 5 year, 7 year

Secondary Outcome Measures

Name	Time	Method
color doppler	3 month, 1 year, 3 year, 5 year, 7 year
phlebography	3 month, 1 year, 3 year, 5 year, 7 year

Trial Locations

Locations (1)

The first affiliated hospital of Sun Yat-Sen University; 🇨🇳 Guang Zhou, Guang dong, China