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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 studied for treating dysfunctional arteriovenous fistulae, the surgically created vein connections used for hemodialysis access. It was evaluated in a Phase 3 trial comparing it with a standard balloon in patients whose fistulae had stopped working properly.
Lutonix DCB is developed by Becton, Dickinson and Company, which trades under the ticker BDX. The company sponsored the clinical program evaluating the device in arteriovenous fistula patients.
Lutonix DCB has been studied in a Phase 3 clinical trial, which is now completed. It is an investigational device rather than an approved product, and the completed study enrolled 285 participants with dysfunctional arteriovenous fistulae.
Lutonix DCB was evaluated in the Phase 3 study NCT02440022, titled a study comparing Lutonix AV drug coated balloon versus standard balloon for treatment of dysfunctional AV fistulae. The trial was active controlled, randomized, completed, enrolled 285 patients, and was conducted in the United States.
The Lutonix DCB Phase 3 trial NCT02440022 was a randomized, active controlled study comparing the drug coated balloon against a standard balloon in patients with dysfunctional arteriovenous fistulae. It was not double blinded, enrolled 285 participants aged 21 years and older, and did not select patients by biomarker.