Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02440022 | Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae | PHASE3 | COMPLETED | 285 | — | — | Jun 1, 2015 | Jun 1, 2018 | May 6, 2020 | 23 | United States |
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...