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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perivascular dexamethasone | Combination Product | Dexamethasone delivery around target vein segment(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Care Connecticut | Darien | Connecticut | 06820 | United States | ||
| University of South Florida |
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| Perivascular sham | Combination Product | Saline delivery around target vein segment(s) |
|
| Tampa |
| Florida |
| 33060 |
| United States |
| Northwestern University Hospital | Chicago | Illinois | 60611 | United States |
| CIS Clinical Research | Houma | Louisiana | 70360 | United States |
| Medstar Health Research Institute | Hyattsville | Maryland | 20782 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| NC Heart and Vascular Research | Raleigh | North Carolina | 27607 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| St John Health System | Bartlesville | Oklahoma | 74006 | United States |
| CardioVoyage | Denison | Texas | 75020 | United States |
| University of Texas, Houston | Houston | Texas | 77494 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23452 | United States |
| Lake Washington Vascular | Bellevue | Washington | 98004 | United States |
| Galway University Hospital | Galway | H91 YR71 | Ireland |
| Guy's and St. Thomas Hospital | London | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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