Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Reverse TAPProcedure: DK crush
- Registration Number
- NCT03714750
- Lead Sponsor
- Tommaso Gori
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reverse TAP Reverse TAP Percutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique DK crush DK crush Percutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method use of coronary wires through study completion, an average of 2 hours amount of coronary wires used during procedure
fluoroscopy time through study completion, an average of 2 hours Time of radiation during intervention
procedural time through study completion, an average of 2 hours time of procedure ("Skin-to-Skin"-time)
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
Percentage of Stenosis in main branch through study completion, an average of 2 hours Percentage of Stenosis in the main branch
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
Trial Locations
- Locations (1)
Center of Cardiology, Cardiology I, university hospital Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany