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

NCT01399463 | Unknown

• 1 other identifier: MUWCard18022011
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

Drug Eluting Stent, Drug Eluting Balloon, Fractional Flow Reserve, DES, DEB, FFR

Outcome Measures

Primary Outcomes (1)

• Loss in fractional flow reserve (FFR) at 6 months for both treatment groups

  6 month

Secondary Outcomes (8)

• 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

• Angiographic in-stent restenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure

  6 month

Study Arms (2)

DEB + BMS

EXPERIMENTAL

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

Device: Angioplasty performed via Paclitaxel Eluting Balloon catheter

Stenting with commonly used Drug Eluting Stents (DES)

ACTIVE COMPARATOR

Device: Angioplasty via DES

Interventions

Angioplasty performed via Paclitaxel Eluting Balloon catheter DEVICE

DEB + BMS

Angioplasty via DES DEVICE

Angioplasty performed via commonly used Drug Eluting Stents

Stenting with commonly used Drug Eluting Stents (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Coronary Artery Disease; Dysequilibrium syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 21, 2011
• Study Start: August 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07