Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)

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.

Study Overview

• Status: Recruiting
• Conditions: Thrombosis, Deep Vein; Iliofemoral; Thrombosis
• Intervention / Treatment: Combination product: Perivascular dexamethasone; Combination product: Perivascular sham

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kirk Seward, PhD; Phone Number: 510-614-4550; Email: kseward@mercatormed.com

Study Locations

• Ireland
  • Galway, Ireland, H91 YR71
    • Recruiting
    • Galway University Hospital
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's and St. Thomas Hospital
• United States
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Recruiting
      • Vascular Care Connecticut
  • Florida
    • Tampa, Florida, United States, 33060
      • Recruiting
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University Hospital
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Recruiting
      • CIS Clinical Research
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Recruiting
      • MedStar Health Research Institute
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • NC Heart and Vascular Research
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • OhioHealth Research Institute
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • Recruiting
      • St John Health System
  • Texas
    • Denison, Texas, United States, 75020
      • Recruiting
      • CardioVoyage
    • Houston, Texas, United States, 77494
      • Recruiting
      • University of Texas, Houston
  • Virginia
    • Norfolk, Virginia, United States, 23452
      • Recruiting
      • Sentara Norfolk General Hospital
  • Washington
    • Bellevue, Washington, United States, 98004
      • Recruiting
      • Lake Washington Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, 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 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 < 9.0 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 length intended for drug treatment exceeds 50 cm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Combination product: Perivascular sham; Saline delivery around target vein segment(s)
Experimental: Treatment	Combination product: Perivascular dexamethasone; Dexamethasone delivery around target vein segment(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mercator MedSystems, Inc.
• Collaborators: University of South Florida; Northwestern University; Stony Brook University; Guy's and St Thomas' NHS Foundation Trust; Memorial Hermann Hospital; Medstar Health Research Institute; NC Heart and Vascular Research, LLC; Sentara Norfolk General Hospital; Lake Washington Vascular; University College Hospital Galway; Vascular Care Connecticut; OhioHealth Research Institute; CIS Clinical Research; St. John Health System, Oklahoma; CardioVoyage, LLC; Charlotte-Mecklenburg Hospital; King County Public Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Inflammation; Thrombosis; Venous Thrombosis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: CIP0217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes