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DEep VEin Lesion OPtimisation (DEVELOP) Trial

NCT03640689 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-03

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcer

Interventions

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

Sponsors & Collaborators

  • National University of Ireland, Galway, Ireland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2024-09-01
Completion
2024-09-01
FDA Device
Yes

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640689 on ClinicalTrials.gov