Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome

• Conditions: Iliac Vein Compression Syndrome

• Registration Number: NCT03309969
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The aim of this study is to compare intravascular ultrasound with venography in the diagnosis and treatment of iliac vein compression syndrome.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-10-13
• Last Update Submitted: 2017-10-13
• Study First Posted: 2017-10-16
• Last Update Posted: 2017-10-16
• Study Start: 2017-10-30
• Primary Completion: 2018-03-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage diameter reduction	1 month	Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography
Percentage area reduction	1 month	Compare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography

Secondary Outcome Measures

Name	Time	Method
CEAP score	18 months	Improvement in Clinical, Etiology, Anatomy, Pathophysiology (CEAP) score
Secondary patency	18 months	Secondary patency can be defined as: with additional revascularization of the target lesions after the first surgery in our department, the target vessels are still patent which measured by ultrasound or magentic resonance venography (MRV) and the diameter reduction is \<50% during follow-up period.
Primary patency	18 months	Primary patency can be defined as without additional revascularization of the target lesions, the target vessels are still patent which measured by ultrasound or magentic resonance venography (MRV) and the diameter reduction is \<50% during follow-up period.

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China