Coronary Artery Disease
Conditions
Keywords
bifurcation coronary lesions, interventional technique of coronary lesions, Double kissing and crush, DK crush, Reverse TAP, reverse T-and-protrusion
Brief summary
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).
Interventions
PROCEDUREDK crush
revascularization of true coronary bifurcation stenosis in DK crush technique
PROCEDUREReverse TAP
revascularization of true coronary bifurcation stenosis in Reverse TAP technique
Sponsors
Tommaso Gori
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Ischemic symptoms, OR * Positive non-invasive imaging for ischemia, OR * Positive Flow Fractional Reserve (FFR), OR * mean lumen area (MLA) \<6mm\^2 for the left main or \<4mm\^2 for epicardial vessels as assessed by intracoronary imaging (IVUS, OCT) * Vessel diameter ≤5.00mm * True bifurcation lesion type 1,1,1 or 0,1,1 * Patient ≥18 years old
Exclusion criteria
* Cardiogenic shock * Trifurcation if all vessels are ≥2.75mm diameter * Either bifurcation vessel not suitable for stenting * History of stenting in target bifurcation lesion * Participation in another investigational drug or device study * Patient unable to give informed consent * Women of child-bearing potential or lactating * In-stent restenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent Expansion in the side branch (defined as the vessel which received the first stent) | through study completion, an average of 2 hours | Ratio of the minimum stent area of the side branch and the maximum stent area of the side branch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedural time | through study completion, an average of 2 hours | time of procedure (Skin-to-Skin-time) |
| use of coronary wires | through study completion, an average of 2 hours | amount of coronary wires used during procedure |
| protocol success | through study completion, an average of 2 hours | the Intervention is performed according to the protocol (including final kissing PTCA) |
| Min. lumen Diameter in main branch | through study completion, an average of 2 hours | Minimum lumen Diameter in the main branch |
| fluoroscopy time | through study completion, an average of 2 hours | Time of radiation during intervention |
| Min. lumen Diameter in side branch | through study completion, an average of 2 hours | Minimum lumen Diameter in the side branch |
| Percentage of Stenosis in side branch | through study completion, an average of 2 hours | Percentage of Stenosis in the side branch |
| Procedural success | through study completion, an average of 2 days | 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 |
| Percentage of Stenosis in main branch | through study completion, an average of 2 hours | Percentage of Stenosis in the main branch |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side branch obstruction | through study completion, an average of 2 hours | optical coherence tomography endpoint, side branch obstruction through malapposed struts expressed as mean ratio between maximum inter-strut opening and side branch ostium diameter |
| Mean lumen area in the main branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, Mean lumen Area in the main branch |
| Strut malapposition at bifurcation | through study completion, an average of 2 hours | optical coherence tomography endpoint, % struts malapposed |
| Minimum lumen diameter in the side branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, Minimum lumen Diameter in the side branch |
| Mean lumen diameter in the side branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, Mean lumen Diameter in the side branch |
| average stent eccentricity index (SEI) in the side branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the side branch |
| average stent eccentricity index (SEI) in the main branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the main branch |
| Minimum lumen diameter in the main branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, Minimum lumen Diameter in the main branch |
| Mean lumen diameter in the main branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, Mean lumen Diameter in the main branch |
| Minimum lumen area in the main branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, Minimum lumen Area in the main branch |
| Minimum lumen area in the side branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, Minimum lumen area in the side branch |
| Mean lumen area in the side branch | through study completion, an average of 2 hours | optical coherence tomography endpoint, Mean lumen Area in the side branch |
Countries
Germany
Outcome results
None listed