Role of IVUS in Management of Iliocaval Obstruction

NCT04024215 | Unknown

• 1 other identifier: IVUS in iliocaval obstruction
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the role of IVUS in

1. 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. 2.comparing diagnostic accuracy of intravascular ultrasound (IVUS) with multiplanar venography and CT venography for iliocaval obstruction.

Conditions

Iliocaval Compression Syndrome

Keywords

intravascular ultrasound

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Primary Patency of the performed procedure

  baseline

• Secondary Patency of the performed procedure

  baseline

• Assisted Primary Patency of the performed procedure

  baseline

Interventions

intravascular ultrasound DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

subjects with with acute or chronic iliocaval obstruction CEAP classification 3-6.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71511, Egypt

RECRUITING

Related Publications (6)

• 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.

  PMID: 19386020 BACKGROUND

• 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.

  PMID: 17540535 BACKGROUND

• 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.

  PMID: 11997362 BACKGROUND

• 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.

  PMID: 11932665 BACKGROUND

• 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.

  PMID: 19560027 BACKGROUND

• 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.

  PMID: 11854730 RESULT

Related Links

• CIRSE Standards of Practice Guidelines on Iliocaval Stenting

MeSH Terms

Conditions

May-Thurner Syndrome

Interventions

Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• moustafa saad khalil, professor

  Assiut University

  STUDY DIRECTOR

• hesham aboelyoun, lecturer

  Assiut University

  STUDY CHAIR

• ahmed hassan bakr, A.professor

  Assiut University

  STUDY CHAIR

Central Study Contacts

sahar hamdi

CONTACT

01016299048; saharhamdiali@gmail.com

ahmed hassan bakr, A. professor

CONTACT

01204510848; ahmedhassan.bakr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: May 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: March 30, 2022
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)