Status:
UNKNOWN
Pressure-wire Guided PTCA: Drug Eluting Stent Versus Drug Eluting Balloon (WinDEB Study)
Lead Sponsor:
Medical University of Vienna
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel disease and side bra...
Detailed Description
This study is a randomized, prospective, multi-center, efficacy study with a DES control group assessing the 6-month loss in FFR in patients treated with the "matrix coated paclitaxel-eluting PTCA-bal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01399463
Start Date
August 1 2011
Last Update
July 21 2011
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