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.
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: 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.
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 between 40 kg/m2 and 45 kg/m2, with significant comorbidity which, in the Investigator's discretion, could impair follow-up or study outcomes.
Body Mass Index > 45 kg/m2.
Parallel
Perivascular dexamethasone
Combination productDexamethasone delivery around target vein segment(s)
Perivascular sham
Combination productSaline delivery around target vein segment(s)
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
Limit the progression to PTS
PTS rate by Villalta score ≥5.
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
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Mercator MedSystems, Inc.
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
