For people ages 18 years and up
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 < 26 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.
o 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)