Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers

NCT07762222 | Recruiting DMC FDA Device

• 1 other identifier: FMASU MD123/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Outcomes of iliac vein stenting with dedicated venous stents in treatment of chronic post-thrombotic venous ulcers Deep vein thrombosis (DVT) affects 1 to 3 individuals per 1000 annually. Among these patients, 20% to 50% may develop post-thrombotic syndrome (PTS), with the likelihood varying based on the extent and location of the thrombus. Notably, despite receiving anticoagulation therapy, 5% to 10% of patients may progress to severe PTS, potentially leading to the development of venous ulcers (Afsha Aurshina, 2018). Chronic venous obstruction (CVO) refers to the impediment of venous flow, typically resulting from either partial or complete blockage of the venous system. This obstruction leads to diminished venous flow and elevated pressure within the affected veins. CVO serves as a broad descriptor for various conditions, including post-thrombotic syndrome (PTS) and nonthrombotic iliac vein lesions (NIVLs). PTS commonly arises as a complication of deep vein thrombosis (DVT), with estimates indicating that up to 50% of patients diagnosed with iliofemoral DVT will develop PTS within two years following their initial diagnosis. (Mohammad E. Barbati, 2024) The study aims to know the outcomes of iliac vein stenting with dedicated venous stenting in the treatment of post-thrombotic syndrome venous ulcer. Type of Study: Prospective single arm cohort study

• Study Setting: Ain Shams University hospitals
• Study Period: 2 years with 6 months follow up
• Sample Size: 20 patients.
• Study Population Patients presenting to the outpatient clinic at Ain Shams University Hospitals with venous ulcers.
• Study Tools
• 20 patients will be selected.
• Written informed consent.
• Full history taking, personal history , risk factors of DVT, presence of any medical illness , assessment of QOL based on CVIQ 20 - questionnaire, list of symptoms, sensations or types of discomfort that you may or may not be experiencing and which may make everyday life hard to bear to a greater or lesser extent.
• Clinical evaluation: based on revised Venous Clinical Severity Score rVCSS , Villalta score and CEAP classification . rVCSS includes 10 items, such as pain, varicose veins, oedema, skin pigmentation, inflammation, skin induration, number of active ulcers, ulcer size, duration of ulcer, and application of pressure therapy. Each item is scored from 0 to 3 according to the severity, and the total score is 30. A higher score indicates higher severity. And using villlata score It can be used to both diagnose and categories the severity of the condition. The Villalta score involves both the patient who grades the presence and severity (0-3 points) of five symptoms ( pain , cramps, heaviness, parasthesia and pruritus ) and and the physician who grades six clinical signs(Pre-tibial oedema, Hyper-pigmentation, Redness, Venous Ectasia, ain on calf compression, ulcers) (0-3 points) after examination of the lower limb. Also the clinical severity of the venous disease will be graded according to the clinical, etiological, anatomical, and pathophysiological (CEAP) scoring system, and assessment of venous ulcer assessment (by onset, course, duration, site, size, shape

Conditions

Vascular; DVT - Deep Vein Thrombosis; Post Thrombotic Syndrome; Venous Ulcer of Leg

Keywords

iliofemoral postthrombotic syndrome; venous ulcer; dedicated iliac venous stenting

Outcome Measures

Primary Outcomes (1)

• complete healing of venous ulcer

  Proportion of participants with complete healing of the venous ulcer at 12 months after iliofemoral venous stenting.

  12 months

Secondary Outcomes (3)

• Time to complete venous ulcer healing

  12 months

• Change in rVCSS

  12 months

• Venous ulcer recurrence

  12 months

Study Arms (1)

Iliofemoral dedicated venous stenting

EXPERIMENTAL

Participants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy.

Procedure: dedicated venous stenting; Device: Dedicated venous stent / iliofemoral dedicated venous stenting

Interventions

dedicated venous stenting PROCEDURE

iliofemoral dedicated venous stenting

Also known as: venoplasty

Iliofemoral dedicated venous stenting

Dedicated venous stent / iliofemoral dedicated venous stenting DEVICE

Participants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy.

Iliofemoral dedicated venous stenting

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic non-healing venous ulcer associated with iliofemoral post-thrombotic syndrome.
• CEAP clinical classification C6.
• Iliofemoral post-thrombotic venous obstruction confirmed by appropriate venous imaging.
• Age 18 years or older.
• Ability to provide informed consent.

You may not qualify if:

• Nonthrombotic iliac vein lesion (NIVL).
• Post-phlebitic femoropopliteal venous lesions with a patent iliac vein.
• CEAP clinical classification other than C6.
• Previous venous intervention.
• Active pathological ulcer unrelated to post-thrombotic venous disease.
• Life expectancy less than 2 years.
• Pregnancy.
• Known allergy to contrast media.
• Contraindication to anesthesia.
• Refusal to participate or inability to provide informed consent.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams univeristy hospital

Cairo, 1181, Egypt

RECRUITING

Related Publications (5)

• Lurie F, Passman M, Meisner M, Dalsing M, Masuda E, Welch H, Bush RL, Blebea J, Carpentier PH, De Maeseneer M, Gasparis A, Labropoulos N, Marston WA, Rafetto J, Santiago F, Shortell C, Uhl JF, Urbanek T, van Rij A, Eklof B, Gloviczki P, Kistner R, Lawrence P, Moneta G, Padberg F, Perrin M, Wakefield T. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):342-352. doi: 10.1016/j.jvsv.2019.12.075. Epub 2020 Feb 27.

  PMID: 32113854 RESULT

• Marston WA, Vasquez MA, Lurie F, Wakefield TW, Rabe E, Shortell CK, Lohr JM, Passman MA, McLafferty RB; American Venous Forum Outcomes Working Group. Multicenter assessment of the repeatability and reproducibility of the revised Venous Clinical Severity Score (rVCSS). J Vasc Surg Venous Lymphat Disord. 2013 Jul;1(3):219-24. doi: 10.1016/j.jvsv.2012.10.059. Epub 2013 May 18.

  PMID: 26992578 RESULT

• Wang J, Smeath E, Lim HY, Nandurkar H, Kok HK, Ho P. Current challenges in the prevention and management of post-thrombotic syndrome-towards improved prevention. Int J Hematol. 2023 Nov;118(5):547-567. doi: 10.1007/s12185-023-03651-6. Epub 2023 Aug 31.

  PMID: 37651058 RESULT

• Pappas CP, Lakhanpal G, Kennedy R, Lakhanpal S, Shahi S, Pappas PJ. Outcomes of iliofemoral venous stenting in women with venous ulcers. J Vasc Surg Venous Lymphat Disord. 2026 Jul;14(4):102492. doi: 10.1016/j.jvsv.2026.102492. Epub 2026 Mar 30.

  PMID: 41921606 RESULT

• Jalaie H, Barbati ME, Piao L, Doganci S, Kucher N, Dumantepe M, Hartung O, Lichtenberg M, Black S, O'Sullivan G, Avgerinos ED, Davies AH, Razavi MK; International CVO Classification Study Group. Prognostic Value of a Classification System for Iliofemoral Stenting in Patients with Chronic Venous Obstruction. Eur J Vasc Endovasc Surg. 2025 Feb;69(2):315-322. doi: 10.1016/j.ejvs.2024.10.002. Epub 2024 Oct 10.

  PMID: 39393577 RESULT

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome; Varicose Ulcer

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nancy salah Nancy Salah

CONTACT

Egypt : 01122646814; postgrad@med.asu.edu.eg

Naglaa Fathy Naglaa Fathy

CONTACT

Egypt : 01507765311

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: choronic non healing venous ulcer patients with post thrombotic syndrome with iliofemoral venous occlusion

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 13, 2026
• Study Start: March 2, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)