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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04647253 | A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) | PHASE3 | ACTIVE NOT_RECRUITING | 600 | — | — | May 11, 2021 | Sep 1, 2027 | May 27, 2026 | 40 | United States |
The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death
| Arm | Type | Description |
|---|---|---|
| AGENT DCB | EXPERIMENTAL | Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). |
| Commercially available, PTCA Dilation Catheter | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AGENT DCB | DEVICE | Drug coated PTCA balloon catheter |
| PTCA balloon catheter | DEVICE | PTCA balloon catheter |
Clinical Inclusion Criteria * Subject must be at least 18 years of age * Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed * Subject is eligible for percutane...