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

Treatment of Coronary Bifurcation Lesions: a Non-inferiority, Randomized, Controlled Procedural Outcomes Trial Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: DK crush; Procedure: Reverse TAP

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Center of Cardiology, Cardiology I, university hospital Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DK crush; Percutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique	Procedure: DK crush; revascularization of true coronary bifurcation stenosis in DK crush technique
Experimental: Reverse TAP; Percutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique	Procedure: Reverse TAP; revascularization of true coronary bifurcation stenosis in Reverse TAP technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tommaso Gori
• Investigators: Principal Investigator: Tommaso Gori, Prof Dr, PhD, Center of Cardiology, Cardiology I, university hospital Mainz

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: bifurcation coronary lesions; interventional technique of coronary lesions; Double kissing and crush; DK crush; Reverse TAP; reverse T-and-protrusion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: TIP TAP I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No