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Perivascular Dexamethasone for Iliofemoral Thrombosis (DEXTERITY-SCI Trial)
DEXTERITY-SCI Trial Summary
This trial is testing whether a local anti-inflammatory drug can help prevent re-thrombosis and improve symptoms for up to 24 months after a DVT recanalization procedure.
DEXTERITY-SCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDEXTERITY-SCI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DEXTERITY-SCI Trial Design
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Who is running the clinical trial?
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- You have had a condition called heparin-induced thrombocytopenia in the past or are currently experiencing it.My targeted vein was successfully reopened and has at least one working inflow vein.I have been on aspirin or a P2Y12 inhibitor for at least 30 days.You have had a stent placed in a vein on the same side of your body as the treatment.I have a significant blood clot in my leg that blocks more than half of the blood flow.I do not have active bleeding, recent severe GI issues, or serious liver problems.I was not able to walk before my deep vein thrombosis happened.I have a blood clot in my main vein that extends at least one centimeter above where my leg veins meet.You have had a bad reaction to heparin, rtPA, dexamethasone sodium phosphate, or iodinated contrast, unless it was a mild or moderate reaction that can be managed with steroids beforehand.My blood clot is longer than 50 cm and needs drug treatment.I understand what the clinical trial involves and its importance.My high blood pressure is under control and below 140 mmHg.My targeted vein segment cannot be reopened.I can take pills and will follow the blood thinner plan.My doctor expects I have less than 2 years to live due to my cancer.I am prescribed a blood thinner for at least 14 days, followed by another for a year.I am between 18 and 89 years old.Your blood tests show low levels of hemoglobin or platelets, or your kidneys are not working well.I have a pulmonary embolism that is not considered low risk.My other leg has a blood clot that needs surgery within 30 days.You cannot have a needle put into your vein.I have had a bleeding stroke or bleeding in my brain/spine.You have a very high body mass index.You are not expected to live for more than 2 years.I cannot undergo certain vein treatments due to severe shortness of breath or a sudden illness.I am willing and able to follow all study requirements, including questionnaires and visits.I am not currently in a drug or device study, except for approved registry studies.I tested negative for COVID-19 recently or have been vaccinated/boosted in the last year.I started having DVT symptoms in my leg 14 to 60 days ago and need a stent.I had treatment for a painful blood clot in a vein within the last year.My leg circulation is severely compromised.I have not had recent major surgery or eye problems.
- Group 1: Treatment
- Group 2: Control
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age restriction set at 55 or below for this medical experiment?
"This research study stipulates that prospective participants must be at least 18 and no older than 89, to meet the qualifications for enrollment."
What is the patient count for this clinical experiment?
"Affirmative. Information recorded on clinicaltrials.gov certifies that this research, initially published in April 15th 2022 is actively recruiting individuals for participation. Sixty people are required to join the study at a single clinic site."
Do I meet the requirements to partake in this research project?
"This research is recruiting 60 people with the diagnosis of iliofemoral thrombosis, aged 18 to 89. To participate in this trial, they must meet these criteria: symptomatic DVT onset within 14-60 days before intervention involving stenting of the relevant vasculature; hemodynamically significant obstruction across at least two veins (>50%); signed consent form for non-standard treatments; willingness to complete follow up visits and questionnaires; male or female between 18 and 89 years old (with pregnancy test results ≤7 days prior if applicable); negative COVID result 5 days before procedure or vaccine/booster record over last"
What supplemental studies have been conducted relating to Perivascular dexamethasone?
"At present, 552 medical studies on Perivascular dexamethasone are underway. Of these trials, 144 are in their final stage of research; Phase 3. While the majority of trails for this intervention originate from Joliet Illinois, 18606 facilities around the world have joined to aid in researching its efficacy."
What medical conditions has Perivascular dexamethasone been found to have a positive effect on?
"Perivascular dexamethasone is a viable option for treating ophthalmia, sympathetic eye disorders, and branch retinal vein occlusions."
Can additional participants join this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical trial began recruitment on April 15th and is still actively looking for participants as of the latest edit date of April 6th. A total of 60 patients are required from a single site."
What safety protocols have been established for Perivascular dexamethasone usage?
"Our assessment of perivascular dexamethasone's safety is a score of 2. This evaluation was made due to the lack clinical data demonstrating its efficacy, yet there are several studies that have established an acceptable level of risk associated with this medication."
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