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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
NCT06492174 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
Conditions Studied
Interventions
- DEVICE AGENT DCB 40 mm
Study Locations (11)
New York
- Columbia University Medical Center — New York
- St. Francis Hospital — Roslyn
Arizona
- Carondelet Medical Group St. Mary's Hospital — Tucson
California
- Cedars Sinai Medical Center — Los Angeles
Georgia
- Emory University Hospital — Atlanta
Michigan
- Henry Ford Hospital — Detroit
Ohio
- Lindner Center for Research and Education at Christ Hospital — Cincinnati
Pennsylvania
- UPMC Pinnacle Health — Wormleysburg
Rhode Island
- Rhode Island Hospital — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-10-07 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06492174
The ClinicalTrials.gov registry entry for NCT06492174 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with In-Stent Restenosis appearing as the primary indexed condition, and to 1 intervention — of which AGENT DCB 40 mm is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06492174 reports 11 study locations spanning 10 distinct geographic areas — top geographies include New York, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06492174 about?
NCT06492174 is a clinical study 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". The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in di...
What is the current status of trial NCT06492174?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2024-10-07. Estimated completion is 2027-12.
What conditions does trial NCT06492174 study?
This clinical trial studies the following conditions: In-Stent Restenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06492174?
The interventions under investigation include: AGENT DCB 40 mm (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06492174?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06492174 being conducted?
This trial has 11 study locations across Arizona, California, Georgia, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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