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

NCT ID: NCT03714750

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2024-04-01

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).

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DK crush

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

Group Type: ACTIVE_COMPARATOR

DK crush

Intervention Type: PROCEDURE

revascularization of true coronary bifurcation stenosis in DK crush technique

Reverse TAP

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

Group Type: EXPERIMENTAL

Reverse TAP

Intervention Type: PROCEDURE

revascularization of true coronary bifurcation stenosis in Reverse TAP technique

Interventions

DK crush

revascularization of true coronary bifurcation stenosis in DK crush technique

Intervention Type: PROCEDURE

Reverse TAP

revascularization of true coronary bifurcation stenosis in Reverse TAP technique

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tommaso Gori

OTHER

Sponsor Role: lead

Responsible Party

Tommaso Gori

Prof. Dr. Tommaso Gori, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tommaso Gori, Prof Dr, PhD

Role: PRINCIPAL_INVESTIGATOR

Center of Cardiology, Cardiology I, University hospital Mainz

Locations

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

References

Abouelnour AE, Olschewski M, Makmur G, Ullrich H, Knorr M, Ahoopai M, Munzel T, Gori T. Six-months clinical and intracoronary imaging follow-up after reverse T and protrusion or double-kissing and crush stenting for the treatment of complex left main bifurcation lesions. Front Cardiovasc Med. 2023 Apr 27;10:1153652. doi: 10.3389/fcvm.2023.1153652. eCollection 2023.

Reference Type: DERIVED

PMID: 37180808 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34816311 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32554736 (View on PubMed)

Other Identifiers

TIP TAP I

Identifier Type: -

Identifier Source: org_study_id