Venogram vs. Intravascular Ultrasound (IVUS) for Diagnosing Iliac Vein Obstruction (NCT02142062) | Clinical Trial Compass
CompletedNot Applicable
Venogram vs. Intravascular Ultrasound (IVUS) for Diagnosing Iliac Vein Obstruction
United States100 participantsStarted 2014-07
Plain-language summary
The purpose of this study is to demonstrate that IVUS identifies more instances of significant iliac and common femoral vein outflow obstruction than multiplanar venography.No hypothesis testing is planned.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must be \> 18 and \< 85 years of age
* Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure
* CEAP clinical classification: C4, C5, or C6 (enrollment of C4 and C5 subjects will be capped at 50, such that at least 50 C6 subjects can be enrolled)
* On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg
* Undergoing iliofemoral and inferior vena caval venography with the intent to treat obstructive lesions
Exclusion Criteria:
* Subject cannot or will not provide written informed consent
* Previous venous stent implantation involving the study leg or inferior vena cava
* Previous venovenous bypass surgery involving the study leg
* Known metal allergy precluding endovascular stent implantation
* Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
* Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
* Severe, untreated (and readily treatable) superficial venous reflux (great saphenous vein \>7 mm in diameter, and/or small saphenous vein \>4 mm in diameter)
* Acute deep venous thrombosis involving either leg
* Known history of chronic total occlusion of the common femoral vein of the study leg.
* Known history of thrombophilia (e.g., protein C or S deficiency, anti-thrombin III deficiency, presence of l…
What they're measuring
1
100 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C4-6 undergoing iliac and common femoral and venography with intention to treat venous outflow obstruction.