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

October 6, 2024 updated by: Tommaso Gori

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stent Expansion in the side branch (defined as the vessel which received the first stent)
Time Frame: through study completion, an average of 2 hours
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
fluoroscopy time
Time Frame: through study completion, an average of 2 hours
Time of radiation during intervention
through study completion, an average of 2 hours
procedural time
Time Frame: through study completion, an average of 2 hours
time of procedure ("Skin-to-Skin"-time)
through study completion, an average of 2 hours
use of coronary wires
Time Frame: through study completion, an average of 2 hours
amount of coronary wires used during procedure
through study completion, an average of 2 hours
protocol success
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
Minimum lumen Diameter in the main branch
through study completion, an average of 2 hours
Percentage of Stenosis in main branch
Time Frame: through study completion, an average of 2 hours
Percentage of Stenosis in the main branch
through study completion, an average of 2 hours
Min. lumen Diameter in side branch
Time Frame: through study completion, an average of 2 hours
Minimum lumen Diameter in the side branch
through study completion, an average of 2 hours
Percentage of Stenosis in side branch
Time Frame: through study completion, an average of 2 hours
Percentage of Stenosis in the side branch
through study completion, an average of 2 hours
Procedural success
Time Frame: through study completion, an average of 2 days
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
average stent eccentricity index (SEI) in the side branch
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
optical coherence tomography endpoint, Mean lumen Area in the side branch
through study completion, an average of 2 hours
Side branch obstruction
Time Frame: through study completion, an average of 2 hours
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
Time Frame: through study completion, an average of 2 hours
optical coherence tomography endpoint, % struts malapposed
through study completion, an average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tommaso Gori

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tommaso Gori, Prof Dr, PhD, Center of Cardiology, Cardiology I, university hospital Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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