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

NCT03714750 | Completed

• 1 other identifier: TIP TAP I
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

bifurcation coronary lesions; interventional technique of coronary lesions; Double kissing and crush; DK crush; Reverse TAP; reverse T-and-protrusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• fluoroscopy time

  through study completion, an average of 2 hours

• procedural time

  through study completion, an average of 2 hours

• use of coronary wires

  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

Other Outcomes (12)

• average stent eccentricity index (SEI) in the side branch

  through study completion, an average of 2 hours

• average stent eccentricity index (SEI) in the main branch

  through study completion, an average of 2 hours

• Minimum lumen diameter in the main branch

  through study completion, an average of 2 hours

Study Arms (2)

DK crush

ACTIVE COMPARATOR

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

Procedure: DK crush

Reverse TAP

EXPERIMENTAL

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

Procedure: Reverse TAP

Interventions

DK crush PROCEDURE

revascularization of true coronary bifurcation stenosis in DK crush technique

DK crush

Reverse TAP PROCEDURE

revascularization of true coronary bifurcation stenosis in Reverse TAP technique

Reverse TAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tommaso Gori: lead

Study Sites (1)

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (3)

• 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.

  PMID: 37180808 DERIVED

• 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.

  PMID: 34816311 DERIVED

• 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.

  PMID: 32554736 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Pressure Ulcer

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tommaso Gori, Prof Dr, PhD

  Center of Cardiology, Cardiology I, University hospital Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Tommaso Gori, PhD

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 22, 2018
• Study Start: October 30, 2018
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

DE (1)