Iliofemoral; ThrombosisPhase 2DEXTERITY-SCINCT04858776
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT
A Phase 2 study testing Perivascular dexamethasone in people with Iliofemoral; Thrombosis, run by Mercator MedSystems, Inc. at 15 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
- Iliofemoral; Thrombosis
- What is being tested?
- Perivascular dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 8 Aug 2022to 31 May 2027
- 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: negative pregnancy test ≤7 days before the procedure, use of highly effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation.
- Negative COVID-19 test result within 5 days prior to procedure or evidence of COVID-19 vaccine or booster within past 12 months.
- Onset of DVT symptoms 14 to 60 days prior to intervention in the study limb with need for stenting of the iliofemoral segment.
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- Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.
- Prescription for at least 14 days low molecular weight heparin followed by therapeutic anticoagulant of investigator's choice for 12-month minimum as part of post-interventional medication regimen.
- Minimum of 30 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor).
- Hemodynamically significant DVT (>50% area obstruction) spanning at least (a) the iliofemoral and common femoral veins or (b) the common femoral vein with extension into the femoral vein and/or profunda vein. Extent of thrombus in the popliteal and calf veins is allowed.
- Successful recanalization of the target vein with at least one patent inflow vein (femoral or profunda).
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 > 40 kg/m2.
- Non-ambulatory status prior to DVT occurrence.
- In the target vein segment: previously treated symptomatic DVT within the previous 12 months.
- In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require surgery in the following 30 days.
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- Limb-threatening circulatory compromise with 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, hypersensitivity, or thrombocytopenia from heparin, Recombinant tissue plasminogen activator (rtPA), dexamethasone sodium phosphate or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- History of, or active heparin-induced thrombocytopenia (HIT).
- Haemoglobin < 9.0 mg/dl, INR > 1.6 before starting anticoagulation, or platelets < 100,000/ml. Moderate renal impairment in diabetic patients (estimated glomerular filtration rate < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated glomerular filtration rate < 30 ml/min).
- Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
- Recent (< 3 mo) internal eye surgery or haemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical delivery, or other invasive procedure.
- History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- Active cancer with a life expectancy of <2 years.
- 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.
- Thrombus of the inferior vena cava (IVC) extending at least one centimeter above the common iliac confluence.
- Inability to obtain venous access.
- Inability to recanalize the target vein segment(s).
- History of ipsilateral venous stent.
- DVT length to be targeted for perivascular drug therapy exceeds 50 cm.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States13 sites
St John Health System
Bartlesville, Oklahoma, 74006
Lake Washington Vascular
Bellevue, Washington, 98004
Northwestern University Hospital
Chicago, Illinois, 60611
OhioHealth Research Institute
Columbus, Ohio, 43214
Vascular Care Connecticut
Darien, Connecticut, 06820
CardioVoyage
Denison, Texas, 75020
CIS Clinical Research
Houma, Louisiana, 70360
University of Texas, Houston
Houston, Texas, 77494
Medstar Health Research Institute
Hyattsville, Maryland, 20782
Sentara Norfolk General Hospital
Norfolk, Virginia, 23452
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
Stony Brook University Hospital
Stony Brook, New York, 11794
University of South Florida
Tampa, Florida, 33060
About this study
Official title: Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)
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 at least 14 days and no more than 60 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
- Iliofemoral; Thrombosis
- Being tested
- Perivascular dexamethasone, Perivascular sham
- Medical subject headings
- 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.
Clinically relevant primary patency
Freedom from loss of patency with associated symptoms
Measured: 6 months
Freedom from major adverse event (MAE)
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 posted26 Apr 2021
- Study start8 Aug 2022
- Primary completion28 Aug 2025
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliofemoral; ThrombosisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercator MedSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858776
- Sponsor's protocol ID
- CIP0218
- Acronym
- DEXTERITY-SCI
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2021
- Last updated
- 25 Jun 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 Jun 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 Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)
- ClinicalTrials.gov ID
- NCT04858776
- Acronym / sponsor ID
- DEXTERITY-SCI / CIP0218
- Conditions
- Iliofemoral; Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mercator MedSystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 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 at least 14 days and no more than 60 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 (11 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: negative pregnancy test ≤7 days before the procedure, use of highly effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation.
- Negative COVID-19 test result within 5 days prior to procedure or evidence of COVID-19 vaccine or booster within past 12 months.
Key exclusion criteria (24 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 > 40 kg/m2.
- Non-ambulatory status prior to DVT occurrence.
- In the target vein segment: previously treated symptomatic DVT within the previous 12 months.
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
Clinically relevant primary patency
Time frame: 6 months
Freedom from loss of patency with associated symptoms
Freedom from major adverse event (MAE)
Time frame: 30 days
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 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 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 Iliofemoral; Thrombosis, run by Mercator MedSystems, Inc. at 15 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 11 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically relevant primary patency (time frame: 6 months). The study lists 2 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 Jun 2026.