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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)

Study acronym: AGENT IDE
StatusActive, Not Recruiting
PhasePhase 3
Started2021-05-11
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 67 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-08-20
26 amendments v41-v66
26 re-verifications since 2024-06-21, no change to tracked fields
2024-05-30
Study Status, Adverse Events v40
Results first postednot stated→2024-05-31
2024-05-24
Study Status, Participant Flow, Adverse Events v39
Re-verified, no change to tracked fields
2024-05-13
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v38
Primary endpoints1 entry, revised
Number of Participants With Target Lesion Failure Rate
2024-04-11
Study Status, References, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v37
Publications5 to 6 entries
Yeh RW, Bachinsky W, Stoler R, Bateman C, Tremmel JA, Abbott JD, Dohad S, Batchelor W, Underwood P, Allocco DJ, Kirtane AJ. Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis. Am Heart J. 2021 Nov;2 [...]
Show 20 earlier versions
2024-03-29
6 amendments v31-v36
6 re-verifications since 2023-11-22, no change to tracked fields
2023-10-04
Study Status v30
Primary completion dateestimated 2023-09→confirmed 2023-10-02
Completion date2027-08→2027-09
2023-09-20
Study Status v29
Primary completion date2023-08→2023-09
2023-08-21
11 amendments v18-v28
11 re-verifications since 2022-10-24, no change to tracked fields
2022-09-13
Study Status, Study Design, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-02→2023-08
Completion date2028-02→2027-08
Study sitesdetails revised at 40 of 40 sites
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
Trial Details
NCT Number NCT04647253
Lead Sponsor Boston Scientific Corporation
Conditions In-Stent Restenosis
Enrollment 600 participants
Start Date 2021-05-11
Primary Completion 2023-10-02 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-18