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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: Angioplasty performed via Paclitaxel Eluting Balloon catheter; Device: Angioplasty via DES

• Registration Number: NCT01399463
• Lead Sponsor: Medical University of Vienna

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 branches by pressure wire guided percutaneous coronary intervention.

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-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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2011-07
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-20
• Last Update Submitted: 2011-07-20
• Study First Posted: 2011-07-21
• Last Update Posted: 2011-07-21
• Study Start: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEB + BMS	Angioplasty performed via Paclitaxel Eluting Balloon catheter	Paclitaxel drug-eluting balloon (DEB) dilatation and bare metal stenting
Stenting with commonly used Drug Eluting Stents (DES)	Angioplasty via DES	-

Primary Outcome Measures

Name	Time	Method
Loss in fractional flow reserve (FFR) at 6 months for both treatment groups	6 month

Secondary Outcome Measures

Name	Time	Method
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	6 month	Percent in-stent stenosis, in-segment stenosis, in-stent late lumen loss and in-segment late lumen loss at 6 months follow-up
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