Thrombosis, Deep VeinPhase 2DEXTERITY-AFPNCT04862468
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
A Phase 2 study testing Perivascular dexamethasone in people with Thrombosis, Deep Vein and Iliofemoral; Thrombosis, run by Mercator MedSystems, Inc. at 22 sites in 3 countries.
Trial summary
This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Thrombosis, Deep Vein, Iliofemoral; Thrombosis
- What is being tested?
- Perivascular dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 29 Oct 2021to 1 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form prior to receiving any non-standard of care, protocol-specific procedures.
- Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits and availability for the duration of the study.
- Male or female, aged 18 to 89 years.
- For females of reproductive potential: use of highly effective contraception (abstinence is acceptable) for at least 1 month prior to study treatment (unless they had given birth within the 1 month prior to study treatment), and agreement to use such a method for at least 30 days after study treatment.
- Onset of acute DVT symptoms of 14 days or less prior to initial intervention in the study limb.
- Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.
Show all 10Show fewer
- 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.
- Minimum of 28 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor) for patients receiving stents.
- DVT located in any of the major femoropopliteal veins (common femoral, femoral, and/or popliteal above the tibial plateau), with possible extension downstream into the iliac veins.
- Successful recanalization of the target vein with removal of acute thrombus.
Who cannot join
- Current enrollment in another non-registry clinical study of systemic drug therapy or another device study that has not completed its primary endpoint, including prior enrollment in this study. Concurrent enrollment in registry studies of approved devices or drugs are acceptable.
- Lack of capability of understanding the nature, significance and implications of the clinical trial.
- Body Mass Index between 40 kg/m2 and 45 kg/m2, with significant comorbidity which, in the Investigator's discretion, could impair follow-up or study outcomes.
- Body Mass Index > 45 kg/m2.
- Non-ambulatory status prior to DVT occurrence.
- In the study leg: current established PTS (Villalta ≥ 5 for more than 14 days), current known symptomatic deep venous insufficiency for more than 14 days, or previous symptomatic DVT within the last 365 days.
Show all 34Show fewer
- In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require a subsequent open or endovascular surgery in the following 30 days.
- In cases with symptoms of limb-threatening circulatory compromise, ankle-brachial index <0.4, absolute ankle pressure <50 mmHg or absolute toe pressure <30 mmHg.
- Pulmonary embolism (PE) defined as either massive (systolic blood pressure < 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled.
- Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
- Allergy or hypersensitivity to any drugs planned for use in the case (including dexamethasone sodium phosphate, iodinated contrast, low molecular-weight heparin, or recombinant tissue plasminogen activator, rtPA, if planned), except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- History of, or active heparin-induced thrombocytopenia (HIT).
- Hemoglobin < 8.0 g/dl.
- INR > 1.6 before starting anticoagulation.
- Platelets < 100,000/ml.
- Severe renal impairment (estimated glomerular filtration rate < 30 ml/min).
- Active bleeding, recent (< 1 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
- Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy.
- Recent (< 10 days) major surgery, trauma, cardiopulmonary resuscitation, or other invasive procedure which, in the Investigator's discretion, could impair follow-up or study outcomes.
- Obstetrical delivery <72 hours prior to procedure.
- Hemorrhagic stroke within the last 365 days.
- Intracranial/intraspinal bleed within the last 365 days.
- Intracranial/intraspinal tumor within the last 365 days.
- Intracranial/intraspinal vascular malformation within the last 365 days.
- Intracranial/intraspinal aneurysm within the last 365 days.
- Active symptomatic COVID-19 infection that, in the Investigator's discretion, could impair follow-up or study outcomes.
- Severe hypertension on repeated readings (systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg). This can be treated, and blood pressure must be stable before venous access is obtained (systolic blood pressure <140 mmHg).
- Pregnant or breastfeeding.
- Life expectancy < 2 years (e.g. due to active cancer).
- Major thrombus of the inferior vena cava (IVC) (occlusive or near-occlusive) extending at least one centimeter above the common iliac confluence.
- Inability to obtain venous access.
- Inability to recanalize the target vein segment with less than 30% residual obstruction due to thrombus.
- History of ipsilateral venous stent.
- DVT target length intended for drug treatment exceeds 50 cm.
Trial locations and contacts
22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 3 countries
United States20 sites, 18 recruiting
- Recruiting
HCA Medical City Arlington
Arlington, Texas, 76015
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
- Recruiting
HCA Florida JFK Hospital
Atlantis, Florida, 33462
- Completed
OhioHealth Research Institute
Columbus, Ohio, 43214
- Recruiting
Vascular Care Connecticut
Darien, Connecticut, 06820
- Recruiting
Englewood Health
Englewood, New Jersey, 07631
- Recruiting
CIS Clinical Research
Houma, Louisiana, 70360
- Recruiting
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
- Recruiting
Medstar Health Research Institute
Hyattsville, Maryland, 20782
- Completed
Baptist Health
Jacksonville, Florida, 32258
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23452
- Recruiting
Providence St. Joseph Hospital
Orange, California, 92868
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
- Recruiting
Baylor Scott & White Hospital
Plano, Texas, 75093
- Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
- Recruiting
HonorHealth
Scottsdale, Arizona, 85260
- Recruiting
UW Medical Center - Northwest
Seattle, Washington, 98133
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
- Recruiting
University of South Florida
Tampa, Florida, 33060
United Kingdom1 site
- Active, not recruiting
Guy's and St. Thomas Hospital
London, SE1 7EH
About this study
Official title: Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)
This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.
- Conditions
- Thrombosis, Deep Vein, Iliofemoral; Thrombosis
- Being tested
- Perivascular dexamethasone, Perivascular sham
- Medical subject headings
- Venous Thrombosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perivascular dexamethasoneCombination product
Dexamethasone delivery around target vein segment(s)
Perivascular shamCombination product
Saline delivery around target vein segment(s)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Combination Product: Perivascular dexamethasone |
| Control | Sham comparator | Not described Receives: Combination Product: Perivascular sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinically relevant primary patency
Rate of freedom from loss of patency (defined as 100% occlusion of unstented vein or 50% stenosis of stented vein measured by duplex ultrasound or angiogram) with associated symptoms
Measured: 6 months
Limit the progression to PTS
PTS rate by Villalta score ≥5.
Measured: 6 months
Rate of freedom from major adverse event (MAE)
Rate of freedom from composite of all-cause death, clinically significant pulmonary embolism, major bleeding, target vessel thrombosis, infection of treatment or insertion site, or AV fistula of treatment site
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start29 Oct 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosis, Deep VeinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercator MedSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862468
- Sponsor's protocol ID
- CIP0217
- Other IDs
- R44HL160434
- Acronym
- DEXTERITY-AFP
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)
- ClinicalTrials.gov ID
- NCT04862468
- Acronym / sponsor ID
- DEXTERITY-AFP / CIP0217
- Conditions
- Thrombosis, Deep Vein, Iliofemoral; Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mercator MedSystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Combination Product: Perivascular dexamethasone |
| Control | Sham comparator | Combination Product: Perivascular sham |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated informed consent form prior to receiving any non-standard of care, protocol-specific procedures.
- Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits and availability for the duration of the study.
- Male or female, aged 18 to 89 years.
- For females of reproductive potential: use of highly effective contraception (abstinence is acceptable) for at least 1 month prior to study treatment (unless they had given birth within the 1 month prior to study treatment), and agreement to use such a method for at least 30 days after study treatment.
- Onset of acute DVT symptoms of 14 days or less prior to initial intervention in the study limb.
Key exclusion criteria (34 listed)
- Current enrollment in another non-registry clinical study of systemic drug therapy or another device study that has not completed its primary endpoint, including prior enrollment in this study. Concurrent enrollment in registry studies of approved devices or drugs are acceptable.
- Lack of capability of understanding the nature, significance and implications of the clinical trial.
- Body Mass Index between 40 kg/m2 and 45 kg/m2, with significant comorbidity which, in the Investigator's discretion, could impair follow-up or study outcomes.
- Body Mass Index > 45 kg/m2.
- Non-ambulatory status prior to DVT occurrence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perivascular dexamethasoneDexamethasone delivery around target vein segment(s) | Combination product | Treatment |
| Perivascular shamSaline delivery around target vein segment(s) | Combination product | Control |
Primary outcome
Rate of clinically relevant primary patency
Time frame: 6 months
Rate of freedom from loss of patency (defined as 100% occlusion of unstented vein or 50% stenosis of stented vein measured by duplex ultrasound or angiogram) with associated symptoms
Limit the progression to PTS
Time frame: 6 months
PTS rate by Villalta score ≥5.
Rate of freedom from major adverse event (MAE)
Time frame: 30 days
Rate of freedom from composite of all-cause death, clinically significant pulmonary embolism, major bleeding, target vessel thrombosis, infection of treatment or insertion site, or AV fistula of treatment site
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Related trials for Thrombosis, Deep Vein
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perivascular dexamethasone in people with Thrombosis, Deep Vein and Iliofemoral; Thrombosis, run by Mercator MedSystems, Inc. at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirk Seward, PhD (510-614-4550, kseward@mercatormed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinically relevant primary patency (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.