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

Study Overview
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Brief Summary
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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 branches by pressure wire guided percutaneous coronary intervention.

Detailed Description
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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-balloon catheter SeQuent® Please and commonly used DES for small vessel de novo and side branch lesions. 100 patients will be studied in total with two equivalent treatment groups DEB & DES of 50 patients each.

Official Title
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Pressure Wire-guided Percutaneous Coronary Intervention of Small Vessels or Side Branches: Functional Outcome of Drug-Eluting Stent (DES) Versus Drug-Eluting Balloon (DEB) With Provisional Bare Metal Stent Implantation

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Angioplasty performed via Paclitaxel Eluting Balloon catheter
* Device: Angioplasty via DES


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEB + BMS<br>Paclitaxel drug-eluting balloon (DEB) dilatation and bare metal stenting | Device: Angioplasty performed via Paclitaxel Eluting Balloon catheter<br> <br> |
| Active Comparator: Stenting with commonly used Drug Eluting Stents (DES)<br> | Device: Angioplasty via DES<br>* Angioplasty performed via commonly used Drug Eluting Stents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss in fractional flow reserve (FFR) at 6 months for both treatment groups |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of acute (up to 48 hours), subacute (up to 30 days) and late stent thrombosis |  | acute: <48h; subacute: < 30days | 
| NACCE rate at 30 days, 6 and 12 months |  | 30days, 6 and 12 month | 
| Procedural success |  |  | 
| Percent in-stent stenosis, in-segment stenosis, in-stent late lumen loss and in-segment late lumen loss at 6 months follow-up | Percent in-stent stenosis, in-segment stenosis, in-stent late lumen loss and in-segment late lumen loss at 6 months follow-up | 6 month | 
| Angiographic in-stent restenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure |  | 6 month | 
| Angiographic in-segment stenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure |  | 6 month | 
| Indication for premature follow-up |  |  | 
| Target vessel failure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stent, Drug Eluting Balloon, Fractional Flow Reserve, DES, DEB, FFR