A prospective, multi-center, 2:1 randomized (AGENT to POBA), controlled, single-blind, superiority trial. Up to 40 sites in the United States, at least 480 subjects will be enrolled in the trial. An interim analysis will be performed prior to the end of the initial enrollment of 480 patients. The final sample size may be increased up to a maximum of 600 subjects enrolled in the trial.
The objective of this study is to assess the safety and effectiveness of the AgentTM 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.
The AgentTM Paclitaxel Coated balloon catheter is indicated for percutaneous transluminal coronary angioplasty (PTCA) in coronary arteries 2.0 mm to 4.0 mm in diameter and up to 26mm in length, for the purpose of improving myocardial perfusion to treat in-stent restenosis (ISR).
Clinical follow-up: in hospital, 30 days, 6 months, 12 months, then annually through 5 years post index procedure.
The study will be considered complete with regard to the primary endpoint after all subjects have completed the 12-month follow-up period. Subjects who are enrolled but who do not receive a study/ control device will be followed through 12 months only.
- Subject is eligible for percutaneous coronary intervention (PCI)
- Subject is willing to comply with all protocol-required follow-up evaluation
- In-stent restenosis in a lesion previously treated with either a drug-eluting stent or bare metal stent, located in a native coronary artery with a visually estimated reference vessel diameter (RVD) > 2.0 mm and ≤ 4.0 mm
- Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 24 months.
- Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
- Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.
The follow up consists of 8 visit total will be involved in hospital, 30 days, 6 months ( these two can be done by telephone or office visit) , 12 months, 2 and 3 years ( office visit) , the 4 and 5 years post index procedure ( telephone or office visit) . Enrolled subjects will be followed for 5 years following the index procedure.
The visits on site will include physical exam, electrocardiogram, blood test (about 2 tablespoons of blood), health assessment questionnaire, medication assessment.