Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT

NCT04858776 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: CIP0218
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 15

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 at least 14 days and no more than 60 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

Iliofemoral; Thrombosis

Outcome Measures

Primary Outcomes (2)

• Clinically relevant primary patency

  Freedom from loss of patency with associated symptoms

  6 months

• Freedom from major adverse event (MAE)

  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: negative pregnancy test ≤7 days before the procedure, use of highly effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation.
• Negative COVID-19 test result within 5 days prior to procedure or evidence of COVID-19 vaccine or booster within past 12 months.
• Onset of DVT symptoms 14 to 60 days prior to intervention in the study limb with need for stenting of the iliofemoral segment.
• Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.
• Prescription for at least 14 days low molecular weight heparin followed by therapeutic anticoagulant of investigator's choice for 12-month minimum as part of post-interventional medication regimen.
• Minimum of 30 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor).
• Hemodynamically significant DVT (\>50% area obstruction) spanning at least (a) the iliofemoral and common femoral veins or (b) the common femoral vein with extension into the femoral vein and/or profunda vein. Extent of thrombus in the popliteal and calf veins is allowed.
• Successful recanalization of the target vein with at least one patent inflow vein (femoral or profunda).

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 \> 40 kg/m2.
• Non-ambulatory status prior to DVT occurrence.
• In the target vein segment: previously treated symptomatic DVT within the previous 12 months.
• In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require surgery in the following 30 days.
• Limb-threatening circulatory compromise with 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, hypersensitivity, or thrombocytopenia from heparin, Recombinant tissue plasminogen activator (rtPA), dexamethasone sodium phosphate or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
• History of, or active heparin-induced thrombocytopenia (HIT).
• Haemoglobin \< 9.0 mg/dl, INR \> 1.6 before starting anticoagulation, or platelets \< 100,000/ml. Moderate renal impairment in diabetic patients (estimated glomerular filtration rate \< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated glomerular filtration rate \< 30 ml/min).
• Active bleeding, recent (\< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
• Recent (\< 3 mo) internal eye surgery or haemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical delivery, or other invasive procedure.
• History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.

Sponsors & Collaborators

• Mercator MedSystems, Inc.: lead

Study Sites (15)

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

RECRUITING

University of South Florida

Tampa, Florida, 33060, United States

RECRUITING

Northwestern University Hospital

Chicago, Illinois, 60611, United States

RECRUITING

CIS Clinical Research

Houma, Louisiana, 70360, United States

RECRUITING

Medstar Health Research Institute

Hyattsville, Maryland, 20782, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

NOT YET RECRUITING

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

RECRUITING

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

RECRUITING

St John Health System

Bartlesville, Oklahoma, 74006, United States

RECRUITING

CardioVoyage

Denison, Texas, 75020, United States

RECRUITING

University of Texas, Houston

Houston, Texas, 77494, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23452, United States

RECRUITING

Lake Washington Vascular

Bellevue, Washington, 98004, United States

RECRUITING

Galway University Hospital

Galway, H91 YR71, Ireland

RECRUITING

Guy's and St. Thomas Hospital

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

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 21, 2021
• First Posted: April 26, 2021
• Study Start: August 8, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

GB (1); US (13); IE (1)