Clinical Research Directory

Clinical Inclusion Criteria: * 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 Angiographic Inclusion Criteria (visual estimate) * 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. * Target lesion length must be ≤ 36 mm (by visual estimate) and must be covered by only one balloon. * Target lesion must have visually estimated stenosis \> 50% and \< 100% in symptomatic patients (\>70% and \<100% in asymptomatic patients) prior to lesion pre-dilation. * Target lesion must be successfully pre-dilated. Note: Successful predilation/pretreatment refers to dilation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C. Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be \>2 * If a non-target lesion is treated, it must be treated first and must be deemed a success. Note: Successful treatment of a non-target lesion is defined as a residual stenosis of ≤ 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI. Clinical Exclusion Criteria: * 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 that has not reached its primary endpoint. * Subject intends to participate 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 the 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 contraindication for contrast dye that in the opinion of the investigator cannot be adequately pre- medicated. * 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. Angiographic Exclusion Criteria (visual estimate) * Target lesion is located within a bifurcation with planned treatment of side branch vessel. * Target lesion is located within a saphenous vein or arterial graft. * Thrombus present in the target vessel * \> 50% stenosis of an additional lesion proximal or clinically significant distal (\>2.0mm RVD) to the target lesion. * Patient with unprotected left main coronary artery disease. (\>50% diameter stenosis)