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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
DK crush
Reverse TAP
Sponsored by
Tommaso Gori
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring bifurcation coronary lesions, interventional technique of coronary lesions, Double kissing and crush, DK crush, Reverse TAP, reverse T-and-protrusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Center of Cardiology, Cardiology I, university hospital MainzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DK crush

Reverse TAP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

fluoroscopy time
Time of radiation during intervention
procedural time
time of procedure ("Skin-to-Skin"-time)
use of coronary wires
amount of coronary wires used during procedure
protocol success
the Intervention is performed according to the protocol (including final kissing PTCA)
Min. lumen Diameter in main branch
Minimum lumen Diameter in the main branch
Percentage of Stenosis in main branch
Percentage of Stenosis in the main branch
Min. lumen Diameter in side branch
Minimum lumen Diameter in the side branch
Percentage of Stenosis in side branch
Percentage of Stenosis in the side branch
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

Full Information

First Posted
October 4, 2018
Last Updated
August 8, 2022
Sponsor
Tommaso Gori
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1. Study Identification

Unique Protocol Identification Number
NCT03714750
Brief Title
Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
Acronym
TIPTAP-I
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tommaso Gori

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
bifurcation coronary lesions, interventional technique of coronary lesions, Double kissing and crush, DK crush, Reverse TAP, reverse T-and-protrusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DK crush
Arm Type
Active Comparator
Arm Description
Percutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique
Arm Title
Reverse TAP
Arm Type
Experimental
Arm Description
Percutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique
Intervention Type
Procedure
Intervention Name(s)
DK crush
Intervention Description
revascularization of true coronary bifurcation stenosis in DK crush technique
Intervention Type
Procedure
Intervention Name(s)
Reverse TAP
Intervention Description
revascularization of true coronary bifurcation stenosis in Reverse TAP technique
Primary Outcome Measure Information:
Title
Stent Expansion in the side branch (defined as the vessel which received the first stent)
Description
Ratio of the minimum stent area of the side branch and the maximum stent area of the side branch
Time Frame
through study completion, an average of 2 hours
Secondary Outcome Measure Information:
Title
fluoroscopy time
Description
Time of radiation during intervention
Time Frame
through study completion, an average of 2 hours
Title
procedural time
Description
time of procedure ("Skin-to-Skin"-time)
Time Frame
through study completion, an average of 2 hours
Title
use of coronary wires
Description
amount of coronary wires used during procedure
Time Frame
through study completion, an average of 2 hours
Title
protocol success
Description
the Intervention is performed according to the protocol (including final kissing PTCA)
Time Frame
through study completion, an average of 2 hours
Title
Min. lumen Diameter in main branch
Description
Minimum lumen Diameter in the main branch
Time Frame
through study completion, an average of 2 hours
Title
Percentage of Stenosis in main branch
Description
Percentage of Stenosis in the main branch
Time Frame
through study completion, an average of 2 hours
Title
Min. lumen Diameter in side branch
Description
Minimum lumen Diameter in the side branch
Time Frame
through study completion, an average of 2 hours
Title
Percentage of Stenosis in side branch
Description
Percentage of Stenosis in the side branch
Time Frame
through study completion, an average of 2 hours
Title
Procedural success
Description
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
Time Frame
through study completion, an average of 2 days
Other Pre-specified Outcome Measures:
Title
average stent eccentricity index (SEI) in the side branch
Description
optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the side branch
Time Frame
through study completion, an average of 2 hours
Title
average stent eccentricity index (SEI) in the main branch
Description
optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the main branch
Time Frame
through study completion, an average of 2 hours
Title
Minimum lumen diameter in the main branch
Description
optical coherence tomography endpoint, Minimum lumen Diameter in the main branch
Time Frame
through study completion, an average of 2 hours
Title
Mean lumen diameter in the main branch
Description
optical coherence tomography endpoint, Mean lumen Diameter in the main branch
Time Frame
through study completion, an average of 2 hours
Title
Minimum lumen area in the main branch
Description
optical coherence tomography endpoint, Minimum lumen Area in the main branch
Time Frame
through study completion, an average of 2 hours
Title
Mean lumen area in the main branch
Description
optical coherence tomography endpoint, Mean lumen Area in the main branch
Time Frame
through study completion, an average of 2 hours
Title
Minimum lumen diameter in the side branch
Description
optical coherence tomography endpoint, Minimum lumen Diameter in the side branch
Time Frame
through study completion, an average of 2 hours
Title
Mean lumen diameter in the side branch
Description
optical coherence tomography endpoint, Mean lumen Diameter in the side branch
Time Frame
through study completion, an average of 2 hours
Title
Minimum lumen area in the side branch
Description
optical coherence tomography endpoint, Minimum lumen area in the side branch
Time Frame
through study completion, an average of 2 hours
Title
Mean lumen area in the side branch
Description
optical coherence tomography endpoint, Mean lumen Area in the side branch
Time Frame
through study completion, an average of 2 hours
Title
Side branch obstruction
Description
optical coherence tomography endpoint, side branch obstruction through malapposed struts expressed as mean ratio between maximum inter-strut opening and side branch ostium diameter
Time Frame
through study completion, an average of 2 hours
Title
Strut malapposition at bifurcation
Description
optical coherence tomography endpoint, % struts malapposed
Time Frame
through study completion, an average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tommaso Gori, Prof Dr, PhD
Phone
+49 (0) 6131 17 2729
Email
tommaso.gori@unimedizin-mainz.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommaso Gori, Prof Dr, PhD
Organizational Affiliation
Center of Cardiology, Cardiology I, University hospital Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Cardiology, Cardiology I, university hospital Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommaso Gori, Prof Dr, PhD
Phone
+49 (0) 6131 17 2729
Email
tommaso.gori@unimedizin-mainz.de
First Name & Middle Initial & Last Name & Degree
Tommaso Gori, Prof Dr, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34816311
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.
Results Reference
derived
PubMed Identifier
32554736
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.
Results Reference
derived

Learn more about this trial

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

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