PEPCAD I. The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel

This is an interventional treatment trial for Coronary Stenosis focused on measuring small vessel, paclitaxel coated balloon catheter, pepcad, drug eluting balloon Read More

Inclusion Criteria:

• Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
• Patients eligible for coronary revascularization by means of PCI
• Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty or coronary artery bypass grafting)
• Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6 months follow-up.
• Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
• Patients must agree to undergo the 6 months angiographic follow-up
• Patients must agree to undergo the 1 and 3 year clinical follow-up
• Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g., balloon angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document
• Patients with medical indication for follow-up angiography
• Reference diameters from 2.25 mm to 2.8 mm and ≤ 22 mm in length
• Diameter stenosis pre procedure must be either > 70 % or >50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, or scintigraphy
• The target lesion must be covered by a single Paclitaxel-eluting balloon

Exclusion Criteria:

• Patients with acute (< 24 h) or recent (≤ 48 hours) myocardial infarction
• Patients with unstable angina pectoris (Braunwald class 3)
• Patients with severe congestive heart failure
• Patients with severe heart failure NYHA IV
• Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mm Hg requiring inotropic support, IABP and/or fluid challenge).
• Women who are pregnant or lactating
• Patients with another coronary stent implanted previously into the target vessel
• Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
• Patient participates in other clinical trials involving any investigational device or drug
• Untreated hyperthyroidism
• Patient has presence or history of severe renal failure (GFR<30ml/min) and is therefore not eligible for angiography. Patient's serum creatinine levels must be documented
• Post transplantation of any organ or immune suppressive medication
• Other disease to jeopardize follow-up (e.g., malignoma)
• Addiction to any drug or to alcohol
• Patients with any type of surgery during the week preceding the interventional procedure
• Evidence of extensive thrombosis within target vessel before the intervention
• Side branch > 2 mm in diameter originating from the lesion
• Bifurcate lesion
• Restenotic lesion
• Multilesion percutaneous coronary intervention within the same artery (a main artery (e.g., LCdx) and its side branch (e.g., OMS) are considered as different arteries)
• Percutaneous coronary intervention of venous graft
• Target segment is occluded (i.e., acute or chronic)
• In-stent restenosis
• Ostial lesion within 2 mm of vessel origin
• Patient is intolerant to aspirin and/or the ADP-antagonists clopidogrel or has a history of neutropenia, thrombocytopenia induced by ADP-antagonists, or severe hepatic dysfunction prohibiting the use of clopidogrel