Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGENT DCB, PTCA balloon catheter · 1 trial · 1 indication
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...
AGENT DCB is a paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter used for the treatment of in-stent restenosis (ISR), a condition where a previously placed coronary stent becomes narrowed again. It is currently being investigated in a Phase 3 clinical trial for this indication.
AGENT DCB is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting a Phase 3 clinical trial to evaluate the device for the treatment of in-stent restenosis.
AGENT DCB is in Phase 3 clinical development. It is an investigational device and has not been approved by the FDA. The ongoing Phase 3 trial is active but not recruiting participants, with a planned enrollment of 600 subjects.
AGENT DCB is being evaluated in a single Phase 3 clinical trial registered as NCT04647253. The trial, titled 'A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR),' is active but not recruiting and is being conducted in the United States.
Yes, AGENT DCB is a paclitaxel-coated PTCA balloon catheter. The drug coating is paclitaxel, which is released locally to the vessel wall during angioplasty. The device is specifically designed to treat in-stent restenosis, where a stent has become blocked again.