Pressure-wire Guided PTCA: Drug Eluting Stent Versus Drug Eluting Balloon (WinDEB Study)

Inclusion Criteria:

• Patients of at least 18 years of age.
• 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 must agree to undergo the angiographic 6-month and clinical follow-ups at 12 and 36 months.
• De novo coronary lesions including side branches in native coronary arteries (reference vessel between ≥ 2.0 and ≤ 3.0 mm, lesion length ≤ 25 mm as angiographically documented)
• 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, scintigraphy, MRT, or suspected based on angina pectoris.
• Fractional Flow Reserve (FFR) must be less or equal to 0.75.

Exclusion Criteria:

• Patients with a life expectancy of less than 12 months
• Patients that were treated with one or more DES during the last 12 months which would not allow 3-month dual antiplatelet therapy if the patient were randomized in the DEB treatment group.
• Patients who are obliged to be on dual antiplatelet aggregation therapy for more than 3 months following study inclusion
• Patients with acute (< 24 h) or recent (48 hours) myocardial infarction
• Patients with severe congestive heart failure or with severe heart failure NYHA IV or with severe valvular heart disease
• Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP and/or fluid challenge)
• DES treated lesion(s) during the last 12 months.
• Thrombus burden (STEMI, NSTEMI) and/or total occlusion in the culprit segment
• In-segment stenosis of the native vessel within the 5 mm adjacent to the stent