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.
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
Masking
SINGLE
Angioplasty performed via commonly used Drug Eluting Stents
Loss in fractional flow reserve (FFR) at 6 months for both treatment groups
Time frame: 6 month
Occurrence of acute (up to 48 hours), subacute (up to 30 days) and late stent thrombosis
Time frame: acute: <48h; subacute: < 30days
NACCE rate at 30 days, 6 and 12 months
Time frame: 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
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
Angiographic in-stent restenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure
Time frame: 6 month
Angiographic in-segment stenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure
Time frame: 6 month
Indication for premature follow-up
Target vessel failure
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