The Clinical Trial for Primary Chronic Venous Insufficiency

This study is currently recruiting participants.

Verified May 2009 by Sun Yat-sen University

Sponsor:

Information provided by:

Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT00931424

First received: June 30, 2009

Last updated: NA

Last verified: May 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 30, 2009

Last Updated Date

June 30, 2009

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

clinical-etiology-anatomic-pathophysiologic classification system [ Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

phlebography [ Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year ] [ Designated as safety issue: No ]
color doppler [ Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Clinical Trial for Primary Chronic Venous Insufficiency

Official Title ^ICMJE

The Clinical Research of Surgery on Primary Chronic Venous Insufficiency

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Chronic Venous Insufficiency

Intervention ^ICMJE

Procedure: valve reconstruction

reconstruct valve at the same time of superficial vein surgery

Study Arm (s)

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

Intervention: Procedure: valve reconstruction
No Intervention: unreconstruction
patients in this group will only have superficial vein surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Completion Date

Not Provided

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

15 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Shen-ming Wang, Professor

+86 020 87755766－8198

shenmingwang@sohu.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00931424

Other Study ID Numbers ^ICMJE

2008001

Has Data Monitoring Committee

Yes

Responsible Party

wang shen-ming, The first affiliated hospital of Sun Yat-Sen university

Study Sponsor ^ICMJE

Sun Yat-sen University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Shen-ming Wang, doctor

First Affiliated Hospital, Sun Yat-Sen University

Information Provided By

Sun Yat-sen University

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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