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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

Study acronym: AGENT IDE
StatusActive, Not Recruiting
PhasePhase 3
Started2024-10-07
View on ClinicalTrials.gov ↗

Amendment history

2026-08-20
minor
7 amendments v20-v26
7 re-verifications since 2026-02-18, no change to tracked fields
2026-01-15
minor
Study Status v19
Primary completion dateestimated 2025-12→confirmed 2025-12-19
2025-11-14
minor
8 amendments v11-v18
8 re-verifications since 2025-04-21, no change to tracked fields
2025-03-24
minor
Study Status, Contacts/Locations v10
Study sites26→11
2025-02-26
minor
Study Status v9
Re-verified, no change to tracked fields
Show 8 earlier versions
2025-01-06
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 26 of 26 sites
2024-12-18
minor
Study Status v7
Primary completion date2025-11→2025-12
Completion date2027-11→2027-12
2024-11-21
minor
Study Status, Contacts/Locations v6
Study sites25→26
2024-10-23
minor
Study Status, Contacts/Locations v5
Primary completion date2025-10→2025-11
Completion date2027-10→2027-11
Start dateestimated 2024-10→confirmed 2024-10-07
Study sites19→25
2024-09-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start date2024-09→2024-10
Study sitesdetails revised at 19 of 19 sites
2024-09-19
minor
Study Status, Contacts/Locations v3
Study sites12→19
2024-08-22
minor
Study Status, Contacts/Locations v2
Start date2024-08→2024-09
Study sites8→12
2024-08-06
minor
Study Status, Contacts/Locations v1
Start date2024-07→2024-08
Study sites0→8
2024-07-01
minor
Original filing
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.
Trial Details
NCT Number NCT06492174
Lead Sponsor Boston Scientific Corporation
Conditions In-Stent Restenosis
Enrollment 20 participants
Start Date 2024-10-07
Primary Completion 2025-12-19 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-17