Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03309969
Enrollment
50
Registered
2017-10-16
Start date
2017-10-30
Completion date
2019-03-01
Last updated
2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iliac Vein Compression Syndrome

Brief summary

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

Interventions

None listed

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage diameter reduction1 monthCompare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography
Percentage area reduction1 monthCompare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography

Secondary

MeasureTime frameDescription
CEAP score18 monthsImprovement in Clinical, Etiology, Anatomy, Pathophysiology (CEAP) score
Primary patency18 monthsPrimary 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.
Secondary patency18 monthsSecondary 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.

Countries

China

Contacts

Primary ContactZhenyu Shi, Doctor
maxshizhenyu@163.com+86 18616880807
Backup ContactYong Ding, Master
Med.YoungDee@gmail.com+86 18702171713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026