NCT03640689

DEep VEin Lesion OPtimisation (DEVELOP) Trial

DEep VEin Lesion OPtimisation (DEVELOP) Trial: A Randomised, Assessor-blinded Feasibility Study of Iliac Vein Intervention for Venous Leg Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National University of Ireland, Galway, Ireland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, single centre, randomised controlled, feasibility study recruiting patients with lower limb venous ulceration and Great Saphenous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (\>50%) iliac vein lesions plus compression therapy. The primary endpoints will be ulcer healing and procedural safety. Secondary endpoints include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow up will be over a five-year period. This feasibility study is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the study to definitively address ulcer-healing rates.

Detailed description

The single main research question for this trial is as follows: in adult patients with venous ulceration and great saphenous vein incompetence; does iliac vein assessment with IVUS and stenting of significant occlusive disease in addition to superficial great saphenous venous ablation and compression compared to superficial venous ablation and compression alone offer improved ulcer healing rates at three months following treatment? Primary Objective To determine whether superficial venous ablation plus early iliac vein interrogation plus endovascular stenting in the presence of significant occlusive disease results in improved venous ulcer healing compared to superficial venous ablation plus compression therapy alone. Secondary Objectives 1\. To determine the relative performance of duplex ultrasound compared to IVUS for the prediction of NIVLs 3. To determine the rate of primary or recurrent ulceration up to five years following intervention 4. To assess patient quality of life in the short and medium term following each mode of intervention

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Endovenous ablation + iliac US +/- iliac stenting	Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required
DEVICE	Endovenous ablation of Great Saphenous Vein	Ablation of the Great Saphenous Vein and subsequent Graduated Compression

Timeline

• Start date: 2019-07-15
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2018-08-21
• Last updated: 2021-03-03

Locations

2 sites across 1 country: Ireland

Regulatory

• FDA-regulated device study