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

Iliac Vein Compression Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03309969
• Other study ID #: B2017-115
• Status: Recruiting
• Phase: N/A
• First received: September 19, 2017
• Last updated: October 13, 2017
• Start date: October 30, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2017
• Source: Shanghai Zhongshan Hospital
• Contact: Zhenyu Shi, Doctor
• Phone: +86 18616880807
• Email: maxshizhenyu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Iliac Vein Compression Syndrome
• May-Thurner Syndrome
• Syndrome

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage diameter reduction	Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography	1 month
Primary	Percentage area reduction	Compare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography	1 month
Secondary	CEAP score	Improvement in Clinical, Etiology, Anatomy, Pathophysiology (CEAP) score	18 months
Secondary	Primary patency	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.	18 months
Secondary	Secondary patency	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.	18 months