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Perivascular Dexamethasone for Deep Vein Thrombosis (DEXTERITY-AFP Trial)
Phase 2
Recruiting
Research Sponsored by Mercator MedSystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen
Post-procedural prescription for at least 28 days low molecular weight heparin followed by therapeutic anticoagulant of investigator's choice for 12 months minimum as part of post-interventional medication regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
DEXTERITY-AFP Trial Summary
This trial is testing a local anti-inflammatory treatment for people who have recently had their DVT recanalized, in order to see if it prevents re-thrombosis and improves symptoms.
Who is the study for?
Adults aged 18-89 with recent deep vein thrombosis (DVT) in the leg, who can take oral medication and agree to long-term anticoagulant therapy. They must not be enrolled in other drug/device trials, have a BMI over 45, severe health conditions that affect study participation or outcomes, known allergies to drugs used in the trial, or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial is testing if injecting dexamethasone directly around veins after DVT removal reduces re-thrombosis and improves symptoms for up to two years. Participants will receive either this treatment or a sham procedure using the Bullfrog® Micro-Infusion Device.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site such as pain or infection, increased blood sugar levels due to dexamethasone (a steroid), and possible systemic effects like mood changes or stomach upset.
DEXTERITY-AFP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills and will follow the blood thinner plan.
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I will be on a blood thinner for at least 13 months after my procedure.
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I started having symptoms of a blood clot in my limb less than 14 days ago.
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I have a blood clot in my thigh vein that may extend to my hip veins.
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I am between 18 and 89 years old.
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My blocked vein was successfully reopened and the clot removed.
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I have been on aspirin or a similar medication for at least 28 days after getting a stent.
DEXTERITY-AFP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of clinically relevant primary patency
Rate of freedom from major adverse event (MAE)
DEXTERITY-AFP Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Sentara Norfolk General HospitalOTHER
11 Previous Clinical Trials
847 Total Patients Enrolled
Guy's and St Thomas' NHS Foundation TrustOTHER
369 Previous Clinical Trials
514,835 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
65 Patients Enrolled for Deep Vein Thrombosis
Memorial Hermann HospitalOTHER
16 Previous Clinical Trials
56,195 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a stent placed in a vein on the same side of your body.I can take pills and will follow the blood thinner plan.I have not had a bleeding stroke in the past year.I have not had eye surgery or a bleeding eye condition in the last 3 months.I am not currently in a drug or device study that hasn't reached its main goal, except for approved registry studies.Your body mass index is higher than 45.I understand what the clinical trial involves and its importance.I have a significant blood clot in my main vein extending above my hip area.I have severe leg circulation issues, confirmed by low pressure readings.I have had a brain or spinal cord blood vessel malformation in the past year.I have a pulmonary embolism that is not considered low risk.I will be on a blood thinner for at least 13 months after my procedure.My vein cannot be fully opened due to a clot.I have not had a brain or spinal aneurysm in the last year.I started having symptoms of a blood clot in my limb less than 14 days ago.I have a blood clot in my thigh vein that may extend to my hip veins.My other leg has a blood clot that needs surgery within 30 days.I was not able to walk before my deep vein thrombosis occurred.I do not have active bleeding, recent severe GI issues, or serious liver problems.You have a body mass index (BMI) between 40 and 45 and other health issues that could make it difficult to participate in the study.I haven't had major surgery or a serious injury in the last 10 days.Your hemoglobin level is less than 9.0 grams per deciliter.I am not allergic to the medications planned for my treatment, except for possible mild to moderate contrast allergies.My blood clot is longer than 50 cm and needs medication.You are unable to have a needle inserted into your veins.I am between 18 and 89 years old.My blocked vein was successfully reopened and the clot removed.My high blood pressure is under control and below 140 mmHg.I have been on aspirin or a similar medication for at least 28 days after getting a stent.I cannot undergo certain vein treatments due to severe breathing problems or a sudden illness.Your blood clotting test shows a value higher than 1.6 before taking a specific type of medication.Your platelet count is less than 100,000 per milliliter.I currently have COVID-19 symptoms that might affect the study.You are not expected to live for more than 2 years because of a serious illness like cancer.I have not had a brain or spinal cord bleed in the last year.I have had leg swelling or pain for more than 14 days, or a blood clot in my leg in the past year.My kidney function is severely impaired.You have had heparin-induced thrombocytopenia in the past or currently have it.You gave birth within the last 72 hours.I have had a brain or spinal cord tumor in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost capacity of participants for this experiment?
"Affirmative. Information hosted on clinicaltrials.gov suggests that this research effort, initially posted on October 29th 2021, is recruiting applicants. A total of 80 individuals are required at a single institution to participate in the trial."
Answered by AI
What precedent of research exists regarding Perivascular dexamethasone?
"Presently, there are 552 clinical trials assessing the efficacy of Perivascular dexamethasone with 144 in Phase 3. Most investigations into this drug occur in Mishawaka, Indiana, though it is also being studied at 18604 other sites worldwide."
Answered by AI
Is there an age limit for enrollment in this clinical experiment?
"According to the trial's prerequisites, individuals who are between 18 and 89 years old can take part in this clinical investigation."
Answered by AI
Are there any remaining vacancies for individuals to participate in this clinical study?
"Indeed, clinicaltrials.gov indicates that the study is currently accepting participants; it was posted on October 29th 2021 and last modified November 1st of the same year. The aim is to recruit 80 patients from a single centre for this trial."
Answered by AI
Am I eligible to participate in this clinical trial?
"Applicants who are between 18 and 89 years of age, and have a confirmed thrombus diagnosis can participate in this trial. A total of 80 people will be enrolled."
Answered by AI
What sort of safety profile has been observed with the administration of Perivascular dexamethasone?
"This drug has been studied for safety, so it was assigned a rating of 2 on our team's scale. Since this is only Phase 2 trial, there are limited clinical data points that demonstrate its efficacy."
Answered by AI
How is Perivascular dexamethasone typically deployed to address pathological conditions?
"Perivascular dexamethasone is oftentimes prescribed to alleviate ophthalmia, sympathetic. It may also be effective in managing branch retinal vein occlusion, macular edema and other related eye conditions."
Answered by AI
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