The Clinical Trial for Primary Chronic Venous Insufficiency

NCT ID: NCT00931424

Last Updated: 2009-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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

Detailed Description

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Conditions

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Primary Chronic Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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reconstruction

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

Group Type EXPERIMENTAL

valve reconstruction

Intervention Type PROCEDURE

reconstruct valve at the same time of superficial vein surgery

unreconstruction

patients in this group will only have superficial vein surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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valve reconstruction

reconstruct valve at the same time of superficial vein surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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The first affiliated hospital of Sun Yat-Sen university

Principal Investigators

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Shen-ming Wang, doctor

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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The first affiliated hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shen-ming Wang, Professor

Role: CONTACT

+86 020 87755766-8198

Facility Contacts

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Shen-ming Wang, Doctor

Role: primary

+86 020 87755766-8198

Other Identifiers

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2008001

Identifier Type: -

Identifier Source: org_study_id

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