Treatment of Coronary Bifurcation Lesions: a Non-inferiority, Randomized, Controlled Procedural Outcomes Trial Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tommaso Gori
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Stent Expansion in the side branch (defined as the vessel which received the first stent)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
DK crush
Percutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique
Intervention: DK crush (Procedure)
Reverse TAP
Percutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique
Intervention: Reverse TAP (Procedure)
Outcomes
Primary Outcomes
Stent Expansion in the side branch (defined as the vessel which received the first stent)
Time Frame: 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 Outcomes
- use of coronary wires(through study completion, an average of 2 hours)
- fluoroscopy time(through study completion, an average of 2 hours)
- procedural time(through study completion, an average of 2 hours)
- protocol success(through study completion, an average of 2 hours)
- Min. lumen Diameter in main branch(through study completion, an average of 2 hours)
- Percentage of Stenosis in main branch(through study completion, an average of 2 hours)
- Min. lumen Diameter in side branch(through study completion, an average of 2 hours)
- Percentage of Stenosis in side branch(through study completion, an average of 2 hours)
- Procedural success(through study completion, an average of 2 days)
Investigators
Tommaso Gori
Prof. Dr. Tommaso Gori, PhD
Johannes Gutenberg University Mainz