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

NCT ID: NCT01399463

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31

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.

Conditions

Coronary Artery Disease

Study Design

• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

DEB + BMS

Paclitaxel drug-eluting balloon (DEB) dilatation and bare metal stenting

Group Type: EXPERIMENTAL

Angioplasty performed via Paclitaxel Eluting Balloon catheter

Intervention Type: DEVICE

Stenting with commonly used Drug Eluting Stents (DES)

Group Type: ACTIVE_COMPARATOR

Angioplasty via DES

Intervention Type: DEVICE

Angioplasty performed via commonly used Drug Eluting Stents

Interventions

Angioplasty performed via Paclitaxel Eluting Balloon catheter

Intervention Type: DEVICE

Angioplasty via DES

Angioplasty performed via commonly used Drug Eluting Stents

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Univ. Klinik für Innere Medizin II; Department of Cardiology

Other Identifiers

MUWCard18022011

Identifier Type: -

Identifier Source: org_study_id