comparison of agent™ and sequent® please paclitaxel coated balloon catheters in coronary in-stent restenosis (agent-isr)

Conditions: Coronary Artery Disease; Coronary Restenosis; Coronary Atherosclerosis; Coronary Arteriosclerosis

Summary: the primary objective of this study is determine the safety and performance of the agent™ paclitaxel-coated ptca balloon catheter compared to the sequent® please paclitaxel-releasing coronary balloon catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis). the performance will be determined at six months post-procedure by quantitative coronary angiography (qca) to measure late lumen loss (lll) in the re-opened stented segment. qca results will be assessed by an independent, blinded angiographic core lab. study statistical hypothesis: the loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the agent™ study device is not larger than the respective lll after treatment with the sequent® please control devices, i.e. study device is non-inferior to the control device with respect to lll.


Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age * subject is willing and able to provide informed consent * subject is eligible for percutaneous coronary intervention * subject is willing to comply with all protocol-required follow-up evaluations * women of child-bearing potential must agree to use a reliable method of contraception * in-stent restenosis in a lesion previously treated with either a drug-eluting or bare metal stent, located in a native coronary artery with a reference vessel diameter ≥ 2.0 mm and ≤ 3.5 mm * target lesion length must be ≤ 28 mm (by visual estimate) and must be covered by only one balloon * target lesion must have visually estimated stenosis ≥ 70% and \< 100% in asymptomatic patients * target lesion must have visually estimated stenosis ≥ 50% and \< 100% in symptomatic patients * thrombolysis in myocardial infarction (timi) grade flow in the target lesion must be ≥ 1 * target lesion must be successfully pre-dilated. exclusion criteria: * patient has life expectancy of less than 24 months * patient with known coronary artery spasm * patient with unprotected left main coronary artery disease * patient has current problems with substance abuse * patient has planned procedure that may cause non-compliance with the protocol or confound data interpretation * patient is participating in another investigational drug or device clinical study that has not reached its primary endpoint * patient intends to participate in another investigational drug or device clinical study within 12 months after the index procedure * woman who is pregnant or nursing * left ventricular ejection fraction \< 25% * patient had pci or other coronary interventions within the last 30 days * planned pci or cabg after the index procedure * patient to receive other pci interventions in the target vessel, such as rotablation, laser atherectomy, cutting balloon, dcb, des, bms, bioabsorbable scaffold etc. * patient to receive dcb in non-target coronary vessels * acute mi \< 72h * cardiogenic shock * known allergies against paclitaxel or other components of the used medical devices * known hypersensitivity or contraindication for contrast dye that cannot be adequately pre-medicated * intolerance to antiplatelet drugs, anticoagulants required for the procedure * platelet count \ 500k/mm3 * patient with renal failure with a serum creatinine of \> 2.5mg/dl who is receiving dialysis or chronic immunosuppressant therapy * target lesion is located within a bifurcation involving a major side branch \> 2 mm in diameter * target lesion is located within a saphenous vein graft or an arterial graft * target lesion with timi grade flow = 0 (total occlusion) * thrombus present in the target vessel * \> 50% stenosis of an additional lesion proximal or distal to the target lesion