A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
600actual
Sites
40
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-05-11 | actual | When the study began enrolling |
| Primary completion | 2023-10-02 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2020-11-30 | actual | When this record first appeared on the registry |
| Results posted | 2024-05-31 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- In-Stent Restenosis
Interventions
- Device: AGENT DCB
- Device: PTCA balloon catheter
Primary outcome
what the primary-completion date above is the date OFNumber of Participants With Target Lesion Failure
measured 12-month
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-04-14 · 16.0 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-04-05 · 826 KB · SAP_001.pdf
Publications
- PMID 38460161 — reports results
- PMID 34314727 — cited as background
- PMID 42558055 — linked by the registry
- PMID 41553096 — linked by the registry
- PMID 41297981 — linked by the registry
- PMID 40803784 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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