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Perivenøs deksametasonterapi: Undersøker reduksjon av betennelse etter fjerning av trombe for å gi fordel ved akutt femoropopliteal DVT (DEXTERITY-AFP)

22. september 2026 oppdatert av: Mercator MedSystems, Inc.

Perivenøs deksametasonterapi: Undersøker reduksjon av betennelse etter fjerning av trombe for å gi fordel ved akutt 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 89 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: Styre
Kombinasjonsprodukt: Perivascular sham

Saline delivery around target vein segment(s)
Eksperimentell: Behandling
Kombinasjonsprodukt: Perivascular dexamethasone

Dexamethasone delivery around target vein segment(s)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mercator MedSystems, Inc.

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. oktober 2021

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

1. februar 2029

Datoer for studieregistrering

Først innsendt

23. april 2021

Først innsendt som oppfylte QC-kriteriene

26. april 2021

Først lagt ut (Faktiske)

28. april 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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