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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01399463
Recruitment Status : Unknown
Verified July 2011 by Medical University of Vienna.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2011
Last Update Posted : July 21, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Angioplasty performed via Paclitaxel Eluting Balloon catheter Device: Angioplasty via DES Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Masking: Single
Official Title: 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
Study Start Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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

Primary Outcome Measures :
  1. Loss in fractional flow reserve (FFR) at 6 months for both treatment groups [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Occurrence of acute (up to 48 hours), subacute (up to 30 days) and late stent thrombosis [ Time Frame: acute: <48h; subacute: < 30days ]
  2. NACCE rate at 30 days, 6 and 12 months [ Time Frame: 30days, 6 and 12 month ]
  3. Procedural success
  4. Percent in-stent stenosis, in-segment stenosis, in-stent late lumen loss and in-segment late lumen loss at 6 months follow-up [ Time Frame: 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

  5. Angiographic in-stent restenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure [ Time Frame: 6 month ]
  6. Angiographic in-segment stenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure [ Time Frame: 6 month ]
  7. Indication for premature follow-up
  8. Target vessel failure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Thomas Neunteufl, MD, Univ. Klinik für Innere Medizin II; Department of Cardiology Identifier: NCT01399463     History of Changes
Other Study ID Numbers: MUWCard18022011
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Medical University of Vienna:
Drug Eluting Stent, Drug Eluting Balloon, Fractional Flow Reserve, DES, DEB, FFR

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action