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

Study Procedures and Interventions:

All participants will receive standardized venous ulcer care, including wound assessment, appropriate dressing according to the amount of exudate, and elastic compression using class II elastic stockings. Wound care will be provided twice weekly in the vascular surgery clinic by the study investigators. Debridement and wound culture with sensitivity testing will be performed when clinically indicated.

Participants assigned to the interventional treatment will undergo endovascular iliac venous recanalization and stenting. The ipsilateral great saphenous vein, popliteal vein, or femoral vein will be used as the preferred venous access according to the anatomical characteristics of each case. Procedures will be performed under ultrasound guidance.

After venous access, an antegrade venogram will be obtained to assess the venous anatomy and determine the location and extent of iliac venous obstruction. A guidewire will be advanced across the obstructed segment, followed by balloon venoplasty using an appropriately sized balloon. A dedicated self-expanding venous stent will then be deployed across the obstructed segment. Stent diameter will be selected according to the venous anatomy and vessel dimensions, with adequate post-dilatation when required. Completion venography will be performed to assess the final venous flow and stent position.

Following the procedure, venous access sites will be compressed with a sterile dressing. Antithrombotic treatment will be administered according to the study protocol. Low-molecular-weight heparin will be administered at a dose of 5000 IU every 12 hours after stent implantation, followed by therapeutic anticoagulation with warfarin targeting an international normalized ratio of 2-3 or rivaroxaban 20 mg once daily for at least 1 year after hospital discharge.

Postoperative Follow-up:

Clinical follow-up will be performed at 7 days, 1 month, 3 months, 6 months, and 12 months after treatment. Follow-up assessments will include venous ulcer healing, ulcer diameter and depth, time to complete healing, and changes in venous clinical severity and quality-of-life scores. Venous duplex ultrasound will be performed during follow-up to assess stent patency. Computed tomography venography will be performed in cases of suspected stent occlusion, recurrent symptoms, or recurrent venous ulceration.

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.