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)

General Information Age Group Adults Status Recruiting Protocol Number NCT04647253 Background Information 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. Offered At Inova Fairfax Hospital 3300 Gallows Road Falls Church, VA 22042 Principal Investigator Wayne Batchelor, MD and Behnam Tehrani, MD Eligibility Information Subject must be at least 18 years of age 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 Subject is eligible for percutaneous coronary intervention (PCI) Subject is willing to comply with all protocol-required follow-up evaluation 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 Ineligibility Information 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 Subject is participating in another investigational drug or device clinical study within 12 months after the index procedure Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to index procedure, except for women who definitely do not have child-bearing potential.) Left ventricular ejection fraction known to be < 25% Subject had PCI or other coronary interventions within the last 30 days Planned PCI or CABG after the index procedure STEMI or QWMI < 72h prior to the index procedure Cardiogenic shock (SBP < 80 mmHg requiring inotropes, IABP or fluid support) Known allergies against paclitaxel or other components of the used medical devices Known hypersensitivity or contraindiction for contrast dye that in the opinion of the investigator cannot be adequately premedicated Intolerance to antiplatelet drugs, anticoagulants required for procedure Platelet count < 100k/mm3 (risk of bleeding) or > 700k/mm3 Subject with renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent) Subject has suspected or proven COVID-19 at present or within the past 4 weeks with resolution of symptoms Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT04647253 Contact Information Contact Name Brian Moore RN Contact Phone 703-776-7995 Contact Email Send Email