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Treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established. While a single stent strategy is simpler and has been often encouraged, a number of studies show that the use of modern stent implantation techniques may bring some advantages in terms of target lesion failure during longer follow-up. Further, single-stent procedures are not possible at all in some settings, for instance when both main and side branch have similar diameters and present both relevant disease, particularly when the angle between the vessels is lower than 70°. Recent randomized data demonstrate the superiority of the technique called double kissing and crush (DK-Crush) over provisional stenting in this setting. The DK-Crush technique is however cumbersome, time-consuming and requires very experienced operators. The investigators therefore plan to undertake a randomized study comparing a novel interventional technique against DK-crush in the setting of true bifurcation lesions (Medina lesions type 1,1,1 or 0,1,1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DK crush | Active Comparator | Percutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique |
|
| Reverse TAP | Experimental | Percutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DK crush | Procedure | revascularization of true coronary bifurcation stenosis in DK crush technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stent Expansion in the side branch (defined as the vessel which received the first stent) | Ratio of the minimum stent area of the side branch and the maximum stent area of the side branch | through study completion, an average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| fluoroscopy time | Time of radiation during intervention | through study completion, an average of 2 hours |
| procedural time | time of procedure ("Skin-to-Skin"-time) |
| Measure | Description | Time Frame |
|---|---|---|
| average stent eccentricity index (SEI) in the side branch | optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the side branch | through study completion, an average of 2 hours |
| average stent eccentricity index (SEI) in the main branch |
Inclusion Criteria:
Patients must meet all of the inclusion criteria:
Documented heart team (as per guidelines) decision for revascularization via PCI
Planned percutaneous coronary intervention (PCI) for a bifurcation stenosis with both branches >2.5mm and with a stenosis >50% and clinical indication to percutaneous intervention, including:
Vessel diameter ≤5.00mm
True bifurcation lesion type 1,1,1 or 0,1,1
Patient ≥18 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tommaso Gori, Prof Dr, PhD | Center of Cardiology, Cardiology I, University hospital Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Cardiology, Cardiology I, university hospital Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37180808 | Derived | Abouelnour AE, Olschewski M, Makmur G, Ullrich H, Knorr M, Ahoopai M, Munzel T, Gori T. Six-months clinical and intracoronary imaging follow-up after reverse T and protrusion or double-kissing and crush stenting for the treatment of complex left main bifurcation lesions. Front Cardiovasc Med. 2023 Apr 27;10:1153652. doi: 10.3389/fcvm.2023.1153652. eCollection 2023. | |
| 34816311 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Reverse TAP | Procedure | revascularization of true coronary bifurcation stenosis in Reverse TAP technique |
|
| through study completion, an average of 2 hours |
| use of coronary wires | amount of coronary wires used during procedure | through study completion, an average of 2 hours |
| protocol success | the Intervention is performed according to the protocol (including final kissing PTCA) | through study completion, an average of 2 hours |
| Min. lumen Diameter in main branch | Minimum lumen Diameter in the main branch | through study completion, an average of 2 hours |
| Percentage of Stenosis in main branch | Percentage of Stenosis in the main branch | through study completion, an average of 2 hours |
| Min. lumen Diameter in side branch | Minimum lumen Diameter in the side branch | through study completion, an average of 2 hours |
| Percentage of Stenosis in side branch | Percentage of Stenosis in the side branch | through study completion, an average of 2 hours |
| Procedural success | procedural success defined by angiographic success (no residual Stenosis of more than 20% at the end of Radiation) AND no periprocedural complications (including STEMI, new Q-wave myocardial infarction (MI), death, stent thrombosis, by-pass surgery, peri-procedural cardiac biomarker release according to the third universal definition of myocardial infarction) at discharge | through study completion, an average of 2 days |
optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the main branch |
| through study completion, an average of 2 hours |
| Minimum lumen diameter in the main branch | optical coherence tomography endpoint, Minimum lumen Diameter in the main branch | through study completion, an average of 2 hours |
| Mean lumen diameter in the main branch | optical coherence tomography endpoint, Mean lumen Diameter in the main branch | through study completion, an average of 2 hours |
| Minimum lumen area in the main branch | optical coherence tomography endpoint, Minimum lumen Area in the main branch | through study completion, an average of 2 hours |
| Mean lumen area in the main branch | optical coherence tomography endpoint, Mean lumen Area in the main branch | through study completion, an average of 2 hours |
| Minimum lumen diameter in the side branch | optical coherence tomography endpoint, Minimum lumen Diameter in the side branch | through study completion, an average of 2 hours |
| Mean lumen diameter in the side branch | optical coherence tomography endpoint, Mean lumen Diameter in the side branch | through study completion, an average of 2 hours |
| Minimum lumen area in the side branch | optical coherence tomography endpoint, Minimum lumen area in the side branch | through study completion, an average of 2 hours |
| Mean lumen area in the side branch | optical coherence tomography endpoint, Mean lumen Area in the side branch | through study completion, an average of 2 hours |
| Side branch obstruction | optical coherence tomography endpoint, side branch obstruction through malapposed struts expressed as mean ratio between maximum inter-strut opening and side branch ostium diameter | through study completion, an average of 2 hours |
| Strut malapposition at bifurcation | optical coherence tomography endpoint, % struts malapposed | through study completion, an average of 2 hours |
| Olschewski M, Ullrich H, Knorr M, Makmur G, Ahoopai M, Munzel T, Gori T. Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions. Clin Res Cardiol. 2022 Jul;111(7):750-760. doi: 10.1007/s00392-021-01972-2. Epub 2021 Nov 24. |
| 32554736 | Derived | Rakhimov K, Buono A, Anadol R, Ullrich H, Knorr M, Ahoopai M, Munzel T, Gori T. Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial. BMJ Open. 2020 Jun 16;10(6):e034264. doi: 10.1136/bmjopen-2019-034264. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |