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| ID | Type | Description | Link |
|---|---|---|---|
| R44HL160434 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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 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.
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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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Limit the progression to PTS | PTS rate by Villalta score ≥5. | 6 months |
| 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 | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirk Seward, PhD | Contact | 510-614-4550 | kseward@mercatormed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence St. Joseph Hospital | Recruiting | Orange | California | 92868 | United States | |
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| Perivascular sham | Combination Product | Saline delivery around target vein segment(s) |
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| Vascular Care Connecticut |
| Recruiting |
| Darien |
| Connecticut |
| 06820 |
| United States |
| HCA Florida JFK Hospital | Recruiting | Atlantis | Florida | 33462 | United States |
| Baptist Health | Recruiting | Jacksonville | Florida | 32258 | United States |
| University of South Florida | Recruiting | Tampa | Florida | 33060 | United States |
| Piedmont Heart Institute | Recruiting | Atlanta | Georgia | 30309 | United States |
| CIS Clinical Research | Recruiting | Houma | Louisiana | 70360 | United States |
| Medstar Health Research Institute | Recruiting | Hyattsville | Maryland | 20782 | United States |
| Englewood Health | Recruiting | Englewood | New Jersey | 07631 | United States |
| Stony Brook University Hospital | Recruiting | Stony Brook | New York | 11794 | United States |
| NC Heart and Vascular Research | Recruiting | Raleigh | North Carolina | 27607 | United States |
| OhioHealth Research Institute | Active, not recruiting | Columbus | Ohio | 43214 | United States |
| St John Health System | Active, not recruiting | Bartlesville | Oklahoma | 74006 | United States |
| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23452 | United States |
| Galway University Hospital | Completed | Galway | H91 YR71 | Ireland |
| Guy's and St. Thomas Hospital | Active, not recruiting | London | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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