Iliac vein stenting with dedicated venous stents for chronic post-thrombotic venous ulcers
Official title: Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
Run by Ain Shams University · NCT07762222 · Data updated 2026-11-12
This study tests whether using dedicated iliac venous stents to reopen obstructed veins helps heal chronic leg ulcers caused by post-thrombotic syndrome in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | March 2, 2025 |
| Main results expected | December 2, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07762222 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older with chronic non-healing iliofemoral post-thrombotic venous ulcers classified as CEAP C6 and confirmed venous obstruction.
✕Probably not a fit
Patients without iliofemoral venous obstruction or with nonthrombotic iliac vein lesions may not benefit from the venous stenting procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with chronic non-healing venous ulcers due to iliofemoral post-thrombotic syndrome receive standard wound care and compression, while a subset undergo endovascular venous recanalization and stenting of the iliac veins. The procedure uses ultrasound guidance, venography, balloon venoplasty, and a dedicated self-expanding venous stent, followed by post-procedure care and antithrombotic management. Outcomes focus on ulcer healing, venous flow, and stent patency, with data collected through clinic visits and imaging. The study aims to determine if the venous intervention improves wound healing beyond standard care alone.
Why it matters
Potential benefit: If successful, the approach could improve healing of chronic venous ulcers and reduce symptoms for patients with iliofemoral post-thrombotic syndrome.
How similar studies have gone: Earlier studies in venous stenting for post-thrombotic syndrome have shown potential benefits in select patients, but robust, definitive evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Ain shams univeristy hospital
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Nancy salah Nancy Salah
- Email: postgrad@med.asu.edu.eg
- Phone: Egypt : 01122646814
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.