Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 2

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

NCT04862468 · tracked via the Priya Life Science Ireland tracker
Phase
Phase 2
Started
2021-10-29
Last updated
2026-09-25

Condition(s) studied

Thrombosis, Deep VeinIliofemoral; Thrombosis

Investigational drug(s) / intervention(s)

Perivascular dexamethasonePerivascular sham

Perivascular dexamethasone: Dexamethasone delivery around target vein segment(s)

Perivascular sham: Saline delivery around target vein segment(s)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
89 Years
Healthy volunteers
No
Inclusion Criteria: 1. Provision of signed and dated informed consent form prior to receiving any non-standard of care, protocol-specific procedures. 2. Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits and availability for the duration of the study. 3. Male or female, aged 18 to 89 years. 4. 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. 5. Onset of acute DVT symptoms of 14 days or less prior to initial intervention in the study limb. 6. Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen. 7. 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. 8. Minimum of 28 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor) for patients receiving stents. 9. 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. 10. Successful recanalization of the target vein with removal of acute thrombus. Exclusion Criteria: 1. 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. 2. Lack of capability of understanding the nature, significance and implications of the clinical trial. 3. 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. 4. Body Mass Index \> 45 kg/m2. 5. Non-ambulatory status prior to DVT occurrence. 6. 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. 7. 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. 8. 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. 9. 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. 10. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness. 11. 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. 12. History of, or active heparin-induced thrombocytopenia (HIT). 13. Hemoglobin \< 8.0 g/dl. 14. INR \> 1.6 before starting anticoagulation. 15. Platelets \< 100,000/ml. 16. Severe renal impairment (estimated glomerular filtration rate \< 30 ml/min). 17. Active bleeding, recent (\< 1 mo) GI bleeding, severe liver dysfunction, bleeding diathesis. 18. Recent (\< 3 mo) internal eye surgery or hemorrhagic retinopathy. 19. 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. 20. Obstetrical delivery \<72 hours prior to procedure. 21. Hemorrhagic stroke within the last 365 days. 22. Intracranial/intraspinal bleed within the last 365 days. 23. Intracranial/intraspinal tumor within the last 365 days. 24. Intracranial/intraspinal vascular malformation within the last 365 days. 25. Intracranial/intraspinal aneurysm within the last 365 days. 26. Active symptomatic COVID-19 infection that, in the Investigator's discretion, could impair follow-up or study outcomes. 27. 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). 28. Pregnant or breastfeeding. 29. Life expectancy \< 2 years (e.g. due to active cancer). 30. Major thrombus of the inferior vena cava (IVC) (occlusive or near-occlusive) extending at least one centimeter above the common iliac confluence. 31. Inability to obtain venous access. 32. Inability to recanalize the target vein segment with less than 30% residual obstruction due to thrombus. 33. History of ipsilateral venous stent. 34. DVT target length intended for drug treatment exceeds 50 cm.

Primary outcome measure(s)

  • Rate of clinically relevant primary patency — 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 — 6 months
    PTS rate by Villalta score ≥5.
  • Rate of freedom from major adverse event (MAE) — 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

Trial sites (22)

FacilityCityRegionStatus
HonorHealth Scottsdale Arizona Recruiting
Providence St. Joseph Hospital Orange California Recruiting
Vascular Care Connecticut Darien Connecticut Recruiting
HCA Florida JFK Hospital Atlantis Florida Recruiting
Baptist Health Jacksonville Florida Completed
University of South Florida Tampa Florida Recruiting
Grady Memorial Hospital Atlanta Georgia Recruiting
Piedmont Heart Institute Atlanta Georgia Recruiting
CIS Clinical Research Houma Louisiana Recruiting
Medstar Health Research Institute Hyattsville Maryland Recruiting
Englewood Health Englewood New Jersey Recruiting
Stony Brook University Hospital Stony Brook New York Recruiting
NC Heart and Vascular Research Raleigh North Carolina Recruiting
OhioHealth Research Institute Columbus Ohio Completed
Allegheny General Hospital Pittsburgh Pennsylvania Recruiting
HCA Medical City Arlington Arlington Texas Recruiting
HCA Houston Healthcare Medical Center Houston Texas Recruiting
Baylor Scott & White Hospital Plano Texas Recruiting
Sentara Norfolk General Hospital Norfolk Virginia Recruiting
UW Medical Center - Northwest Seattle Washington Recruiting
Galway University Hospital Galway Ireland Completed
Guy's and St. Thomas Hospital London United Kingdom Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04862468 on ClinicalTrials.gov ↗ ← All trials in Ireland