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

Clinical Inclusion Criteria:

• Subject must be at least 18 years of age

• Subject (or legal guardian) understands the trial requirements and the treatmentprocedures, and provides written informed consent before any trial-specific tests orprocedures 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 ofcontraception 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 stentor bare metal stent, located in a native coronary artery with a visually estimatedreference vessel diameter (RVD) > 2.0 mm and ≤ 4.0 mm.

• Target lesion length must be ≤ 36 mm (by visual estimate) and must be covered byonly one balloon.

• Target lesion must have visually estimated stenosis > 50% and < 100% in symptomaticpatients (>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 asuccess.

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 orconfound data interpretation.

• Subject is participating in another investigational drug or device clinical studythat has not reached its primary endpoint.

• Subject intends to participate in another investigational drug or device clinicalstudy within 12 months after the index procedure.

• Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 daysprior to the index procedure, except for women who definitely do not havechild-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 ofthe 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 (dialysisdependent).

• Subject has suspected or proven COVID-19 at present or within the past 4 weeks withresolution of symptoms.

Angiographic Exclusion Criteria (visual estimate)

• Target lesion is located within a bifurcation with planned treatment of side branchvessel.

• 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)