Iliocaval Compression Syndrome Clinical Trial
Official title:
Role of Intravascular Ultrasound(IVUS) in Management of Acute and Chronic Iliocaval Obstruction
Verified date | May 2020 |
Source | Assiut University |
Contact | sahar hamdi |
Phone | 01016299048 |
saharhamdiali[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To assess the role of IVUS in
1. Providing diagnostic important data as: luminal diameters, cross-sectional area,
assessment of potential thrombus volume which enables optimal choice of appropriate
angioplasty technique, endovascular device guidance, and their impact on procedural
technical success and patency rates.
2. comparing diagnostic accuracy of intravascular ultrasound (IVUS) with multiplanar
venography and CT venography for iliocaval obstruction.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | March 30, 2022 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 1-acute iliocaval obstruction 2-chronic iliocaval obstruction with CEAP clinical class 3-6 3- acute on top of chronic iliocaval obstruction with CEAP clinical class 3-6 4-symptomatic acute femoro-iliocaval occlusion who underwent successful thrombolysis Exclusion Criteria: 1 - concomitant peripheral arterial disease in the affected limb. 2-life expectancy less than 5 years. 3- pregnancy 4- malignancy 5-raised renal chemistry 6-pelvic fibrosis 7- contraindication to anti-coagulation therapy. 8-congenital venous malformations 9-Not providing informed consent 10-Any concurrent disease as heart failure |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University Hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
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. — View Citation
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. — View Citation
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. Epub 2007 May 30. — View Citation
Neglén P, Raju S. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg. 2002 Apr;35(4):694-700. — View Citation
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. — View Citation
Vedantham S, Grassi CJ, Ferral H, Patel NH, Thorpe PE, Antonacci VP, Janne d'Othée 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage diameter change in iliocaval segment | Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography and interventional venogram | baseline | |
Primary | 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 | |
Primary | 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 | |
Secondary | Primary Patency of the performed procedure | uninterrupted vessel patency with no procedure performed on the treated segment. | baseline | |
Secondary | Secondary Patency of the performed procedure | whenever maintenance of patency required secondary intervention at the target lesion. | baseline | |
Secondary | Assisted Primary Patency of the performed procedure | cases in which a revision of the revascularization method is applied before vessel occlusion occurs as prophylactic interventions. | baseline |