Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty

PHASE4CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

April 30, 2014

Conditions
Stable AnginaCoronary Stenosis
Interventions
DEVICE

FFR - guided DEB angioplasty

DEB-only angioplasty is attempted in all patients. At baseline, quantitative coronary angiography (QCA) and fractional flow reserve (FFR) using an intracoronary standard bolus of adenosine are performed. If FFR at baseline is greater than 0.8, PCI is deferred, otherwise predilation with a non-coated balloon is performed. In case of severe recoil (\> 50% residual stenosis) or flow-limiting dissection the procedure is deemed not suitable for DEB-only angioplasty and stent implantation is performed at the discretion of the operator. In all other cases, the lesion is treated using a Sequent Please® paclitaxel-eluting balloon (DEB). QCA and FFR measurements are repeated and the result is considered satisfactory if there is no flow-limiting dissection, residual stenosis \< 40% and FFR \> 0.8.

DEVICE

Provisional bare metal stenting

In case of suboptimal results after the FFR-guided DEB angioplasty described above, a bare metal stent is implanted inside the segment previously treated by DEB.

Trial Locations (1)

07747

University Hospital of Jena, Heart Center, Division of Cardiology, Jena

All Listed Sponsors
collaborator

B. Braun Melsungen AG

INDUSTRY

lead

University of Jena

OTHER

NCT02120859 - Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty | Biotech Hunter | Biotech Hunter