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

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

Study Overview

• Status: Unknown
• Conditions: Iliac Vein Compression Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • 180 Fenglin Road
      • Contact: Zhenyu Shi, doctor; Phone Number: +86 18616880807; Email: maxshizhenyu@163.com
      • Principal Investigator: Zhenyu Shi, Professor
      • Sub-Investigator: Yong Ding, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with suspicious iliac vein compression syndrome

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
observation group; Subjects with suspicious iliac vein compression syndrome were included in the observation group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CEAP score	Improvement in Clinical, Etiology, Anatomy, Pathophysiology (CEAP) score	18 months
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 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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Peripheral Vascular Diseases; Syndrome; May-Thurner Syndrome
• Other Study ID Numbers: B2017-115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No