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Lutonix DCB · 1 trial · 1 indication
Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.
The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated).
| Arm | Type | Description |
|---|---|---|
| Lutonix DCB | EXPERIMENTAL | Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. |
| Standard Balloon Angioplasty Catheter | ACTIVE_COMPARATOR | Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. |
| Name | Type | Description |
|---|---|---|
| Lutonix DCB | COMBINATION_PRODUCT | - |
| Standard Balloon Angioplasty Catheter | DEVICE | - |
| Percutaneous Transluminal Angiography | PROCEDURE | Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. |
Inclusion Criteria: 1. Age ≥21 years; 2. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF); 3. Arteriovenous fistula located...
Lutonix DCB is a drug-coated balloon used for the treatment of dysfunctional arteriovenous fistulae. It is being developed for patients with arteriovenous fistula, a condition where a surgically created connection between an artery and a vein is used for dialysis access. The drug is currently in Phase 3 clinical development.
Lutonix DCB is a drug-coated balloon that delivers a therapeutic agent directly to the site of the arteriovenous fistula. The specific molecular target is not disclosed in the available information. The balloon is designed to treat dysfunctional arteriovenous fistulae by delivering the drug to the affected area during angioplasty.
Lutonix DCB is developed by Becton, Dickinson and Company, which trades under the ticker BDX on the New York Stock Exchange. The company is conducting clinical trials to evaluate the safety and efficacy of this drug-coated balloon for the treatment of dysfunctional arteriovenous fistulae.
Lutonix DCB is in Phase 3 clinical development. It is an investigational drug-coated balloon being studied for the treatment of dysfunctional arteriovenous fistulae. The Phase 3 trial has been completed, and the drug is not yet approved by regulatory authorities.
Lutonix DCB has one completed Phase 3 clinical trial registered as NCT02440022. This study compared the Lutonix AV drug-coated balloon to a standard balloon for the treatment of dysfunctional arteriovenous fistulae. The trial enrolled 285 participants in the United States and was active-controlled.
Lutonix DCB is a drug-coated balloon, which is different from a standard balloon. In clinical trials, it was compared against a standard balloon to evaluate its effectiveness in treating dysfunctional arteriovenous fistulae. The drug coating is intended to provide an additional therapeutic benefit compared to standard angioplasty balloons.