Clinical trial NCT03714750: Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
Official title: Treatment of Coronary Bifurcation Lesions: a Non-inferiority, Randomized, Controlled Procedural Outcomes Trial Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Stent Expansion in the side branch (defined as the vessel which received the first stent)
timeFrame: through study completion, an average of 2 hours
Secondary outcomes:
measure: fluoroscopy time
timeFrame: through study completion, an average of 2 hours
measure: procedural time
timeFrame: through study completion, an average of 2 hours
measure: use of coronary wires
timeFrame: through study completion, an average of 2 hours
measure: protocol success
timeFrame: through study completion, an average of 2 hours
measure: Min. lumen Diameter in main branch
timeFrame: through study completion, an average of 2 hours
measure: Percentage of Stenosis in main branch
timeFrame: through study completion, an average of 2 hours
measure: Min. lumen Diameter in side branch
timeFrame: through study completion, an average of 2 hours
measure: Percentage of Stenosis in side branch
timeFrame: through study completion, an average of 2 hours
measure: Procedural success
timeFrame: through study completion, an average of 2 days
Other outcomes:
measure: average stent eccentricity index (SEI) in the side branch
timeFrame: through study completion, an average of 2 hours
measure: average stent eccentricity index (SEI) in the main branch
timeFrame: through study completion, an average of 2 hours
measure: Minimum lumen diameter in the main branch
timeFrame: through study completion, an average of 2 hours
measure: Mean lumen diameter in the main branch
timeFrame: through study completion, an average of 2 hours
measure: Minimum lumen area in the main branch
timeFrame: through study completion, an average of 2 hours
measure: Mean lumen area in the main branch
timeFrame: through study completion, an average of 2 hours
measure: Minimum lumen diameter in the side branch
timeFrame: through study completion, an average of 2 hours
measure: Mean lumen diameter in the side branch
timeFrame: through study completion, an average of 2 hours
measure: Minimum lumen area in the side branch
timeFrame: through study completion, an average of 2 hours
measure: Mean lumen area in the side branch
timeFrame: through study completion, an average of 2 hours
measure: Side branch obstruction
timeFrame: through study completion, an average of 2 hours
measure: Strut malapposition at bifurcation
timeFrame: through study completion, an average of 2 hours
Locations:
city: Mainz
country: Germany
facility: Center of Cardiology, Cardiology I, university hospital Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: Center of Cardiology, Cardiology I, University hospital Mainz
name: Tommaso Gori, Prof Dr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.