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Recombinant tissue plasminogen activator · 2 trials · 10 indications
Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| A-Intervention | EXPERIMENTAL | PCDT with intrathrombus delivery of recombinant tissue plasminogen activator (rt-PA, maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm |
| B-Control | NO_INTERVENTION | Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio 2.0 - 3.0). Elastic compression stockings will be prescribed |
| EkoSonic® Endovascular System | EXPERIMENTAL | Participants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively. |
| Name | Type | Description |
|---|---|---|
| Recombinant tissue plasminogen activator (rt-PA) | DRUG | Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device. |
| recombinant tissue plasminogen activator | DRUG | Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device. |
| EKOS EkoSonic Endovascular System | DEVICE | 24 mg of r-tPA will be delivered through the EkoSonic Endovascular System. |
Inclusion Criteria: * Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein. Exclusion Criteria: * Age less than 16 years or greater than 75 years. * Symptom duration \> 14 days for the DVT episode in the index leg (i.e., non-acute DVT). * In the index leg: established...
Recombinant tissue plasminogen activator is used for the treatment of Pulmonary Embolism and Deep Vein Thrombosis. It is being developed by Boston Scientific Corporation (BSX) and is currently in Phase 3 clinical development for these cardiovascular conditions.
Recombinant tissue plasminogen activator is a small molecule that works by targeting and breaking down blood clots. It is being studied for its ability to treat Pulmonary Embolism and Deep Vein Thrombosis by dissolving the clots that cause these conditions.
Recombinant tissue plasminogen activator is being developed by Boston Scientific Corporation, which trades under the ticker BSX. The company is conducting Phase 3 clinical trials to evaluate the drug for the treatment of Pulmonary Embolism and Deep Vein Thrombosis.
Recombinant tissue plasminogen activator is in Phase 3 clinical development. It is an investigational drug being studied for Pulmonary Embolism and Deep Vein Thrombosis, and it is not yet approved by the FDA. Two Phase 3 trials have been completed.
Recombinant tissue plasminogen activator has been studied in two completed Phase 3 trials. NCT00790335 enrolled 692 patients with Deep Vein Thrombosis, and NCT01513759 enrolled 150 patients with Pulmonary Embolism. Both trials were conducted in the United States.
Recombinant tissue plasminogen activator is a form of tissue plasminogen activator, which is commonly known as alteplase. It is being developed by Boston Scientific Corporation for the treatment of Pulmonary Embolism and Deep Vein Thrombosis.