A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

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.
• •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)