Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty (OCTOPUS-2)
Stable Angina, Coronary Stenosis
About this trial
This is an interventional treatment trial for Stable Angina focused on measuring PCI, Drug-eluting balloon (DEB), Fractional flow reserve (FFR)
Eligibility Criteria
Inclusion Criteria:
- Indication for elective PCI according to the guidelines of European Society of Cardiology, American Heart Association and American College of Cardiology
- Age > 18 years, written consent
- Native de novo coronary lesion suitable for angioplasty and OCT imaging
Exclusion Criteria:
- Pregnancy and breast feeding mother
- Co-morbidity with an estimated life expectancy of < 50 % at 1 year
- Scheduled major surgery in the next 6 months
- Not able to give informed written consent or non-compliance
- Participation in other PCI trial
- Acute coronary syndromes and cardiogenic shock
- Known allergy to aspirin, thienopyridines or against taxol derivates
- Culprit lesion within the proximal 10 mm of the right or left coronary artery
- Saphenous vein grafts
- Estimated lesion length > 30 mm
Sites / Locations
- University Hospital of Jena, Heart Center, Division of Cardiology
Arms of the Study
Arm 1
Arm 2
Experimental
Other
FFR - guided DEB angioplasty
DEB angioplasty with provisional bare metal stenting
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.
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.