Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT

NCT04862468 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: CIP0217R44HL160434
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 17

Brief 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 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

Outcome Measures

Primary Outcomes (3)

• 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

  6 months

• Limit the progression to PTS

  PTS rate by Villalta score ≥5.

  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

  30 days

Study Arms (2)

Treatment

EXPERIMENTAL

Combination Product: Perivascular dexamethasone

Control

SHAM COMPARATOR

Combination Product: Perivascular sham

Interventions

Perivascular dexamethasone COMBINATION_PRODUCT

Dexamethasone delivery around target vein segment(s)

Treatment

Perivascular sham COMBINATION_PRODUCT

Saline delivery around target vein segment(s)

Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mercator MedSystems, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (17)

Providence St. Joseph Hospital

Orange, California, 92868, United States

RECRUITING

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

RECRUITING

HCA Florida JFK Hospital

Atlantis, Florida, 33462, United States

RECRUITING

Baptist Health

Jacksonville, Florida, 32258, United States

RECRUITING

University of South Florida

Tampa, Florida, 33060, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

CIS Clinical Research

Houma, Louisiana, 70360, United States

RECRUITING

Medstar Health Research Institute

Hyattsville, Maryland, 20782, United States

RECRUITING

Englewood Health

Englewood, New Jersey, 07631, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

RECRUITING

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

ACTIVE NOT RECRUITING

St John Health System

Bartlesville, Oklahoma, 74006, United States

ACTIVE NOT RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23452, United States

RECRUITING

Galway University Hospital

Galway, H91 YR71, Ireland

COMPLETED

Guy's and St. Thomas Hospital

London, SE1 7EH, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kirk Seward, PhD

CONTACT

510-614-4550; kseward@mercatormed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: October 29, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); IE (1); GB (1)