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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01399463
• Other study ID #: MUWCard18022011
• Status: Not yet recruiting
• Phase: N/A
• First received: July 20, 2011
• Last updated: July 20, 2011
• Start date: August 2011

Study information

• Verified date: July 2011
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Angioplasty performed via Paclitaxel Eluting Balloon catheter

• Angioplasty via DES
Angioplasty performed via commonly used Drug Eluting Stents

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss in fractional flow reserve (FFR) at 6 months for both treatment groups		6 month
Secondary	Occurrence of acute (up to 48 hours), subacute (up to 30 days) and late stent thrombosis		acute: <48h; subacute: < 30days
Secondary	NACCE rate at 30 days, 6 and 12 months		30days, 6 and 12 month
Secondary	Procedural success
Secondary	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
Secondary	Angiographic in-stent restenosis rate of the target lesion (= 50 % stenosis) at 6 months from the procedure		6 month
Secondary	Angiographic in-segment stenosis rate of the target lesion (= 50 % stenosis) at 6 months from the procedure		6 month
Secondary	Indication for premature follow-up
Secondary	Target vessel failure