NCT04024215|Unknown
Role of IVUS in Management of Iliocaval Obstruction
Role of Intravascular Ultrasound(IVUS) in Management of Acute and Chronic Iliocaval Obstruction
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Role of Intravascular Ultrasound(IVUS) in Management of Acute and Chronic Iliocaval Obstruction
Sponsor study identifier
observational
70
1 country
1
Study Start
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To assess the role of IVUS in
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2019
Actual (reported)July 18, 2019
Actual (reported)May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Percentage diameter change in iliocaval segment
Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography and interventional venogram
baseline
Percentage area change in iliocaval segment
Compare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography and interventional venogram
baseline
technical success of the preformed procedure of endovascular intervention
patency of the treated vessel segment with\\20 % residual stenosis and without dissection or extravasation.
baseline
Primary Patency of the performed procedure
baseline
Secondary Patency of the performed procedure
baseline
Assisted Primary Patency of the performed procedure
baseline
IVUS creates axial images perpendicular to the long axis of the catheter by transmitting sound waves covering 360 degrees around the tip of the catheter, which is delivered into the lumen of the vessel over a guidewire.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
subjects with with acute or chronic iliocaval obstruction CEAP classification 3-6.
Assiut University Hospital
Asyut, 71511, Egypt
Renner R, Gebhardt C, Simon JC, Seikowski K. Changes in quality of life for patients with chronic venous insufficiency, present or healed leg ulcers. J Dtsch Dermatol Ges. 2009 Nov;7(11):953-61. doi: 10.1111/j.1610-0387.2009.07082.x. English, German.
Labropoulos N, Borge M, Pierce K, Pappas PJ. Criteria for defining significant central vein stenosis with duplex ultrasound. J Vasc Surg. 2007 Jul;46(1):101-7. doi: 10.1016/j.jvs.2007.02.062. Epub 2007 May 30.
moustafa saad khalil, professor
Assiut University
hesham aboelyoun, lecturer
Assiut University
ahmed hassan bakr, A.professor
Assiut University
First Submitted
July 16, 2019
First Posted
July 18, 2019
Study Start
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 30, 2021
The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter
Contact the study team to confirm eligibility.
Forauer AR, Gemmete JJ, Dasika NL, Cho KJ, Williams DM. Intravascular ultrasound in the diagnosis and treatment of iliac vein compression (May-Thurner) syndrome. J Vasc Interv Radiol. 2002 May;13(5):523-7. doi: 10.1016/s1051-0443(07)61535-8.
Neglen P, Raju S. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg. 2002 Apr;35(4):694-700. doi: 10.1067/mva.2002.121127.
Vedantham S, Grassi CJ, Ferral H, Patel NH, Thorpe PE, Antonacci VP, Janne d'Othee BM, Hofmann LV, Cardella JF, Kundu S, Lewis CA, Schwartzberg MS, Min RJ, Sacks D; Technology Assessment Committee of the Society of Interventional Radiology. Reporting standards for endovascular treatment of lower extremity deep vein thrombosis. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S391-408. doi: 10.1016/j.jvir.2009.04.034. No abstract available.
Buckley CJ, Arko FR, Lee S, Mettauer M, Little D, Atkins M, Manning LG, Patterson DE. Intravascular ultrasound scanning improves long-term patency of iliac lesions treated with balloon angioplasty and primary stenting. J Vasc Surg. 2002 Feb;35(2):316-23. doi: 10.1067/mva.2002.119755.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 11, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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