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Perivenøs dexamethasonterapi: Undersøgelse af reduktion af inflammation efter trombefjernelse for at give fordel ved akut femoropopliteal DVT (DEXTERITY-AFP)

22. september 2026 opdateret af: Mercator MedSystems, Inc.

Perivenøs dexamethasonterapi: Undersøgelse af reduktion af inflammation efter trombefjernelse for at give gavn ved akut 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, SE1 7EH
        • Aktiv, ikke rekrutterende
        • Guy's and St. Thomas Hospital
  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85260
        • Rekruttering
        • HonorHealth
    • California
      • Orange, California, Forenede Stater, 92868
        • Rekruttering
        • Providence St. Joseph Hospital
    • Connecticut
      • Darien, Connecticut, Forenede Stater, 06820
        • Rekruttering
        • Vascular Care Connecticut
    • Florida
      • Atlantis, Florida, Forenede Stater, 33462
        • Rekruttering
        • HCA Florida JFK Hospital
      • Jacksonville, Florida, Forenede Stater, 32258
        • Afsluttet
        • Baptist Health
      • Tampa, Florida, Forenede Stater, 33060
        • Rekruttering
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30303
        • Rekruttering
        • Grady Memorial Hospital
      • Atlanta, Georgia, Forenede Stater, 30309
        • Rekruttering
        • Piedmont Heart Institute
    • Louisiana
      • Houma, Louisiana, Forenede Stater, 70360
        • Rekruttering
        • CIS Clinical Research
    • Maryland
      • Hyattsville, Maryland, Forenede Stater, 20782
        • Rekruttering
        • Medstar Health Research Institute
    • New Jersey
      • Englewood, New Jersey, Forenede Stater, 07631
        • Rekruttering
        • Englewood Health
    • New York
      • Stony Brook, New York, Forenede Stater, 11794
        • Rekruttering
        • Stony Brook University Hospital
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Rekruttering
        • NC Heart and Vascular Research
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43214
        • Afsluttet
        • OhioHealth Research Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Rekruttering
        • Allegheny General Hospital
    • Texas
      • Arlington, Texas, Forenede Stater, 76015
        • Rekruttering
        • HCA Medical City Arlington
      • Houston, Texas, Forenede Stater, 77004
        • Rekruttering
        • HCA Houston Healthcare Medical Center
      • Plano, Texas, Forenede Stater, 75093
        • Rekruttering
        • Baylor Scott & White Hospital
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23452
        • Rekruttering
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98133
        • Rekruttering
        • UW Medical Center - Northwest
  • Irland
      • Galway, Irland, H91 YR71
        • Afsluttet
        • Galway University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 89 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Styring
Kombinationsprodukt: Perivascular sham

Saline delivery around target vein segment(s)
Eksperimentel: Behandling
Kombinationsprodukt: Perivascular dexamethasone

Dexamethasone delivery around target vein segment(s)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of clinically relevant primary patency
Tidsramme: 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
6 months
Limit the progression to PTS
Tidsramme: 6 months

PTS rate by Villalta score ≥5.
6 months
Rate of freedom from major adverse event (MAE)
Tidsramme: 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
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mercator MedSystems, Inc.

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. oktober 2021

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

23. april 2021

Først indsendt, der opfyldte QC-kriterier

26. april 2021

Først opslået (Faktiske)

28. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIP0217
  • R44HL160434 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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