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Label indication Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. FDA label
Also known as Recombinant tissue plasminogen activator (rt-PA), rt-PA, Activase, Alteplase, t-PA
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...
Top 3 of 12 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 5 | PHASE3 | REGN7508, REGN9933 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE2 | Thrombate III |
| Johnson & Johnson | JNJ | 1 | - | Rivaroxaban |
Recombinant tissue plasminogen activator is being studied for the treatment of deep vein thrombosis and pulmonary embolism, which are cardiovascular conditions involving blood clots. It is an investigational therapy in Phase 3 clinical development, not an approved product for these indications.
Recombinant tissue plasminogen activator targets coagulation factor IX, also known as F9. It is classified as an exogenous protein therapeutic. By acting on this target within the coagulation cascade, the agent is intended to promote clot breakdown in conditions such as deep vein thrombosis and pulmonary embolism.
Boston Scientific Corporation, which trades under the ticker BSX, is the developer of recombinant tissue plasminogen activator. The company is advancing the agent through clinical testing for deep vein thrombosis and pulmonary embolism.
Recombinant tissue plasminogen activator is in Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA for the studied indications. The Phase 3 program includes completed trials in pulmonary embolism and deep vein thrombosis.
Recombinant tissue plasminogen activator has been evaluated in two completed Phase 3 trials. NCT01513759 studied ultrasound-accelerated thrombolysis in submassive and massive pulmonary embolism, enrolling 150 participants. NCT00790335 examined catheter-directed thrombolysis for acute venous thrombosis, including deep vein thrombosis, and enrolled 692 participants.
Yes, recombinant tissue plasminogen activator is also known as rt-PA. Both names refer to the same investigational agent being developed by Boston Scientific Corporation for deep vein thrombosis and pulmonary embolism.