Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation

July 4, 2024 updated by: Enrico Cerrato, San Luigi Gonzaga Hospital

Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation: Insights From TREX Registry

Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. According to DEFINITION criteria, PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization (TVR) compared to Provisional Stenting
  2. The Double-Kissing Crush stenting (DK-Crush) has been tested with the Culotte and the Classic Crush techniques in the unprotected left main disease (ULMD) and in no-ULMD setting, respectively, showing better clinical outcomes.
  3. However, due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush, it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation
  4. The DK-Crush technique has never been tested with the External Minicrush, leaving the operators to choose one or the other according to their experience and preferences.
  5. The T-stenting And Minimal Protrusion (TAP) is a two-stent technique described to treat coronary bifurcation after provisional treating. Compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting.
  6. Nowadays, no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
  7. The issue's importance is highlighted by higher rates of stent thrombosis (ST) and in-stent restenosis (ISR) of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8.
  8. Consequently, investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR.

Study Type

Observational

Enrollment (Estimated)

382

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 Backup

Study Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

ACS or CCS patients with complex coronary bifurcation lesions with the indication of PCI.

Description

Inclusion Criteria:

  • Patients >18 years of age
  • Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina)
  • Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1

Exclusion Criteria:

  • Patients who do not want or cannot sign the informed consent for the procedure.
  • Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe.
  • Patients with a life expectancy of <1 year.
  • Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy.
  • Pregnant women.
  • Patients who cannot take antiplatelet therapy for any reason.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T-stenting And Minimal Protrusion

Percutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC).

The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath.

Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily).

The procedural steps of the technique are described below:

  • MV stenting
  • Distal rewiring towards SB
  • Kissing Balloon for opening distal struts towards SB
  • SB stent implantation
  • Final Kissing Balloon
Procedure: Percutaneous Coronary Intervention

Percutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation.

The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique.
External Minicrush

Percutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC).

The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath.

Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily).

The procedural steps of the technique are described below:

  • SB stent deployment with protrusion into MB
  • Crush the SB stent with a balloon inflating into MB (>0.5 mm of the SB stent)
  • MB stent deployment

  • Rewiring

    • POT
    • KBI
    • Final POT technique
Procedure: Percutaneous Coronary Intervention

Percutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation.

The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 5-years
a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
5-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent thrombosis (ST)
Time Frame: 5-years
Thrombosis of the stent after PCI
5-years
Intrastent-restenosis (ISR)
Time Frame: 5-years
Intrastent restenosis with >50% of the stent diameter
5-years
Target Vessel MI (TVMI)
Time Frame: 5-years
Target vessel myocardial infarction at follow-up
5-years

Collaborators and Investigators

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

Sponsor

San Luigi Gonzaga Hospital

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)

June 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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