Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting (TIPTAP-I)

Tommaso Gori

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: DK crush; Procedure: Reverse TAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03714750

TIP TAP I

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

DK crush

Active Comparator group

Description:

Percutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique

Treatment:

Procedure: DK crush

Reverse TAP

Experimental group

Description:

Percutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique

Treatment:

Procedure: Reverse TAP