At a glance
ClinicalIndex Comparison RecordPhase 3Active· 600 enrolled
Drug / intervention
AGENT DCB +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In Brief
A Phase 3 clinical trial evaluating AGENT DCB and PTCA balloon catheter for In-Stent Restenosis. Active but no longer recruiting, targeting 600 participants across 40 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIn-Stent Restenosis
CountriesUnited States
Collaborators--
Timeline
Phase 3Active
2021202220232024202520262027
First PostedNov 2020
Enrollment StartMay 2021
Primary CompletionOct 2023
TodayJul 2026
Study CompletionSep 2027
First PostedNov 30, 2020
Enrollment StartMay 11, 2021
Primary CompletionOct 2, 2023
Study CompletionSep 1, 2027
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.6 years ago
Interventions
AGENT DCBdevice
Drug coated PTCA balloon catheter
PTCA balloon catheterdevice
PTCA balloon catheter