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Status unknownNCT06484647Updated Jul 8, 2024

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

An observational study in Coronary Artery Disease, Ischemic Heart Disease and Chronic Coronary Syndrome, sponsored by San Luigi Gonzaga Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.

Sponsored by San Luigi Gonzaga Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
382
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Coronary Artery Disease
  • Ischemic Heart Disease
  • Chronic Coronary Syndrome
  • Acute Coronary Syndrome

Keywords

  • Percutaneous Coronary Intervention (PCI)
  • Coronary Artery Disease (CAD)
  • Coronary Bifurcation Lesion (CBL)
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 382 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

San Luigi Gonzaga Hospital is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
382 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

Interventions

  • ProcedurePercutaneous 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.

06

What researchers measure

Primary outcomes

  1. Target Lesion Failure (TLF)

    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)

    Time frame: 5-years

Secondary outcomes

  1. Stent thrombosis (ST)

    Thrombosis of the stent after PCI

    Time frame: 5-years

  2. Intrastent-restenosis (ISR)

    Intrastent restenosis with \>50% of the stent diameter

    Time frame: 5-years

  3. Target Vessel MI (TVMI)

    Target vessel myocardial infarction at follow-up

    Time frame: 5-years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Piedimonte G, Cerrato E, Azzalini L, Quiros A, Di Fonzo R, Maffi V, Bosco M, Vizzari G, Carciotto G, Maiellaro F, Mangione R, Calderone D, Borgi M, Leoncini M, Tomassini F, Rolfo C, Pavani M, Franze A, Zanda G, Zecchino S, La Manna A, Galassi A, Varbella F. Minicrush or T-Stenting and Minimal Protrusion in Complex Coronary Bifurcation Lesions: The Multicenter TREX Registry. Circ Cardiovasc Interv. 2026 Sep 14:e016666. doi: 10.1161/CIRCINTERVENTIONS.126.016666. Online ahead of print. PubMed 42734069 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06484647
Lead sponsor
San Luigi Gonzaga Hospital
Responsible party
Enrico Cerrato (Medical Doctor, MD, San Luigi Gonzaga Hospital) — Principal investigator
First posted
Jul 3, 2024
Start date
Jun 1, 2024
Primary completion
Aug 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Jul 8, 2024

Study contacts

Giulio Piedimonte, MD
Contact
giulio.piedimonte@gmail.com
+393201764900
Enrico Cerrato, MD, PhD
Contact
enrico.cerrato@gmail.com
+393479317104

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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