NCT03262987

Brief Summary

May-Thurner syndrome is the result of compression of the left common iliac vein between the right common iliac artery and overlying vertebrae. In This Study , We will detect the role of color doppler US in the diagnosis of May-Thurner Syndrome in comparison to Direct CT Venography

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 24, 2017

Last Update Submit

August 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome

    Determine the sensitivity, specificity and accuracy of non invasive color doppler ultrasound, using direct and indirect ultrasonographic signs, in the diagnosis of May-Thurner Syndrome , considering direct CT Venography as the gold standard for this diagnosis.

    1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Patients suffering from advanced chronic venous insufficiency in the left leg.

You may qualify if:

  • advanced chronic venous insufficiency submitted to clinical treatment for at least 1 year with no response.
  • Subject must be \> 18 and \< 80 years of age.
  • informed consent document before the planned procedure.
  • On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg.

You may not qualify if:

  • Previous venous stent implantation involving the study leg or inferior vena cava
  • Previous venovenous bypass surgery involving the study leg
  • Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication.
  • Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment).
  • Acute deep venous thrombosis involving either leg.
  • Known history of chronic total occlusion of the common femoral vein of the study leg.
  • Venous compression caused by tumor encasement.
  • Venous outflow obstruction caused by tumor thrombus.
  • Elevated baseline blood creatinine (value greater than the upper limit of the normal range).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

May-Thurner Syndrome

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesPeripheral Vascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mohamed Koraim, Ass. Prof.

    Assiut university, Egypt

    STUDY CHAIR

Central Study Contacts

Omar Mokhtar, M.B.B.CH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

October 1, 2017

Primary Completion

October 31, 2018

Study Completion

December 30, 2018

Last Updated

August 28, 2017

Record last verified: 2017-08