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)

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 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

For more information, please visit: https://clinicaltrials.gov/study/NCT04647253

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

1. Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed.
2. Subject is eligible for percutaneous coronary intervention (PCI).
3. Subject is willing to comply with all protocol-required follow-up evaluation.
4. Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.

1. Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 24 months.
2. Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
3. Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.)
4. Left ventricular ejection fraction known to be < 25%.
5. Planned PCI or CABG after the index procedure.
6. Known hypersensitivity or contraindication for contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.