Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome
1 other identifier
observational
50
1 country
1
Brief Summary
The aim of this study is to compare intravascular ultrasound with venography in the diagnosis and treatment of iliac vein compression syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
October 16, 2017
CompletedStudy Start
First participant enrolled
October 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedOctober 16, 2017
September 1, 2017
4 months
September 19, 2017
October 13, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage diameter reduction
Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography
1 month
Percentage area reduction
Compare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography
1 month
Secondary Outcomes (3)
CEAP score
18 months
Primary patency
18 months
Secondary patency
18 months
Study Arms (1)
observation group
Subjects with suspicious iliac vein compression syndrome were included in the observation group.
Eligibility Criteria
Subjects with suspicious iliac vein compression syndrome
You may qualify if:
- Age: 18 to 90 years
- Willing to participate in and sign the informed consent
- Patients with suspicious iliac vein stenosis or compression presented by preoperative magnetic resonance venography (MRV)
- Patent common femoral vein and/or femoral vein of the study leg
- Undergoing iliofemoral venography with the intend to treat potential iliac vein compression syndrome
You may not qualify if:
- Not providing informed consent
- Venous compression caused by pelvic tumors or fibroid uterus
- Previous stent implantation or venovenous bypass surgery of the study leg
- Known metal allergy precluding the possibility of stent implantation
- Known iodine allergy or severe renal insufficient function which are unsuitable for venography
- Pregnant or planning to be pregnant recently
- Acute deep vein thrombosis or tumor thrombus involving the study leg
- Know history of thrombophilia (e.g. protein C or S deficiency, anti-thrombin III deficiency, etc )
- Any concurrent disease, for example, heart failure, might make the patients unsuitable for surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2017
First Posted
October 16, 2017
Study Start
October 30, 2017
Primary Completion
March 1, 2018
Study Completion
March 1, 2019
Last Updated
October 16, 2017
Record last verified: 2017-09