Stents for Venous Insufficiency
Phase-Based Progress Estimates
Effectiveness
Safety
Venous Insufficiency+10 More
Stents - DeviceEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial will test if using image-guided, endovascular therapy to treat iliac-obstructive post thrombotic syndrome is effective in reducing disease severity and improving quality of life.
Eligible Conditions
- Venous Insufficiency
- Thrombosis
- Deep Vein Thrombosis
- Venous Reflux
- Venous Leg Ulcer (VLU)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: over 6 months follow-up
over 6 months follow-up
PTS Severity
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Non-Endovascular Therapy - Control
1 of 2
Endovascular Therapy - Intervention
1 of 2
Active Control
Experimental Treatment
374 Total Participants · 2 Treatment Groups
Primary Treatment: Stents · No Placebo Group · N/A
Endovascular Therapy - Intervention
Device
Experimental Group · 1 Intervention: Stents · Intervention Types: DeviceNon-Endovascular Therapy - ControlNoIntervention Group · 1 Intervention: Non-Endovascular Therapy - Control · Intervention Types:
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 6 months follow-up
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,789 Previous Clinical Trials
2,271,502 Total Patients Enrolled
Ontario Clinical Oncology Group (OCOG)OTHER
60 Previous Clinical Trials
20,289 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,673 Previous Clinical Trials
30,828,282 Total Patients Enrolled
1 Trials studying Venous Insufficiency
25 Patients Enrolled for Venous Insufficiency
St. Luke's Hospital, Kansas City, MissouriOTHER
3 Previous Clinical Trials
1,586 Total Patients Enrolled
Suresh Vedantham, M.D.Principal InvestigatorClinical Coordinating Center at Washington University School of Medicine
1 Previous Clinical Trials
692 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:People who have disabling PTS, which is defined by having chronic venous disease for more than three months in a leg with a history of DVT, and also having a substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, will not be able to participate in this study.
The person has a problem with their iliac vein, as indicated by an occlusion (blockage) or 50% stenosis (narrowing) on a venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS)
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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