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.
Please see NCT04647253 for the prospective, randomized, multi-center, single blind trial comparing AGENT DCB to balloon angioplasty (POBA). The Long Lesion Cohort is a non-randomized, single arm cohort of subjects with ISR of a previously treated lesion ≥ 26 mm and ≤ 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Drug coated PTCA balloon catheter 40 mm size
Carondelet Medical Group St. Mary's Hospital
Tucson, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Number of Participants With Target Lesion Failure
The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death
Time frame: 12-month
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Henry Ford Hospital
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, United States
UPMC Pinnacle Health
Wormleysburg, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Centennial Medical Center
Nashville, Tennessee, United States
...and 1 more locations