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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB + BMS | Experimental | Paclitaxel drug-eluting balloon (DEB) dilatation and bare metal stenting |
|
| Stenting with commonly used Drug Eluting Stents (DES) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angioplasty performed via Paclitaxel Eluting Balloon catheter | Device |
| ||
| Angioplasty via DES |
| Measure | Description | Time Frame |
|---|---|---|
| Loss in fractional flow reserve (FFR) at 6 months for both treatment groups | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| C535731 | Dysequilibrium syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Device |
Angioplasty performed via commonly used Drug Eluting Stents |
|
| 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 | 6 month |
| Angiographic in-stent restenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure | 6 month |
| Angiographic in-segment stenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure | 6 month |
| Indication for premature follow-up |
| Target vessel failure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |