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AGENT DCB 40 mm · 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 40 mm | EXPERIMENTAL | Agent DCB 40 mm 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). |
| Name | Type | Description |
|---|---|---|
| AGENT DCB 40 mm | DEVICE | Drug coated PTCA balloon catheter 40 mm size |
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 percutan...
AGENT DCB 40 mm is used for the treatment of in-stent restenosis (ISR), a condition where a previously placed stent becomes narrowed again. It is a paclitaxel-coated PTCA balloon catheter designed to deliver the drug to the affected area during a percutaneous coronary intervention.
AGENT DCB 40 mm 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 clinical trials to evaluate the device for the treatment of in-stent restenosis.
AGENT DCB 40 mm is in Phase 3 clinical development. It is an investigational device, meaning it has not yet been approved by regulatory authorities for commercial use. The ongoing Phase 3 trial is assessing its safety and effectiveness in patients with in-stent restenosis.
AGENT DCB 40 mm is being evaluated in a Phase 3 clinical trial with the identifier NCT06492174. This trial, titled 'A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort,' is active but not recruiting participants in the United States.
Yes, AGENT DCB 40 mm is a specific size of the Agent Paclitaxel Coated PTCA Balloon Catheter. The device is designed to treat in-stent restenosis by delivering paclitaxel, an antiproliferative drug, to the vessel wall to prevent further narrowing.