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
  Purpose

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


Condition Intervention
Primary Chronic Venous Insufficiency
Procedure: valve reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Research of Surgery on Primary Chronic Venous Insufficiency

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: January 2006
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: reconstruction
patients in this group will have both valve reconstruction and superficial vein surgery
Procedure: valve reconstruction
reconstruct valve at the same time of superficial vein surgery
No Intervention: unreconstruction
patients in this group will only have superficial vein surgery

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931424

Contacts
Contact: Shen-ming Wang, Professor +86 020 87755766-8198 shenmingwang@sohu.com

Locations
China, Guang dong
The first affiliated hospital of Sun Yat-Sen University Recruiting
Guang Zhou, Guang dong, China, 510080
Contact: Shen-ming Wang, Doctor    +86 020 87755766-8198    shenmingwang@sohu.com   
Principal Investigator: Shen-ming Wang, professor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Shen-ming Wang, doctor First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: wang shen-ming, The first affiliated hospital of Sun Yat-Sen university
ClinicalTrials.gov Identifier: NCT00931424     History of Changes
Other Study ID Numbers: 2008001
Study First Received: June 30, 2009
Last Updated: June 30, 2009
Health Authority: China:Ministry of Health of People's Republic of China

Keywords provided by Sun Yat-sen University:
Primary Chronic Venous Insufficiency
surgery
reconstruction
valve

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014