The Clinical Trial for Primary Chronic Venous Insufficiency

Sun Yat-sen University

Status: Unknown

Conditions: Primary Chronic Venous Insufficiency

Treatments: Procedure: valve reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT00931424

2008001

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

reconstruction

Experimental group

Description:

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

Treatment:

Procedure: valve reconstruction

unreconstruction

No Intervention group

Description:

patients in this group will only have superficial vein surgery