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Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation (T-REX)

Primary Purpose

Coronary Artery Disease, Coronary Stenosis, Coronary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sponsored by
San Luigi Gonzaga Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Reverse TAP, External Minicrush, Coronary bifurcation lesion

Eligibility Criteria

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

Inclusion Criteria: Patients >18 years old; Patients with an indication of PCI, including Chronic Coronary syndrome (CCS) and Acute Coronary Syndrome (ACS), according to current guidelines recommendations; According to Medina and Definition criteria, patients with at least true and complex coronary lesions involved in coronary bifurcation. Exclusion Criteria: Patients that refused informed consent; Patients without valid vascular access that could make unsafe PCI; Patients with an expected life of less than one year; Patients with scheduled major surgery that required prolonged DAPT interruption; Pregnant patients; Patients with DAPT contraindications.

Sites / Locations

  • Ciriè Hospital
  • Ospedale Santa Croce
  • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
  • L'Azienda Ospedaliera (AO) S. Croce e Carle
  • Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Reverse TAP

External Minicrush

Arm Description

Outcomes

Primary Outcome Measures

Target Lesion Failure (TLF) (Composite of all causes of death, non-fatal TVMI, ischemia-driven target lesion revascularisation (TLR) + Definite or probable ST+ ISR >50% at planned coronary angiography or Coro-TC.
The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).

Secondary Outcome Measures

Cardiac death + TVMI + ST
The investigators check mid-term cardiovascular clinical performance between the two techniques.
Cardiac death + TVMI + ST +TLR
The investigators check mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site.

Full Information

First Posted
March 11, 2023
Last Updated
April 14, 2023
Sponsor
San Luigi Gonzaga Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05782738
Brief Title
Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
Acronym
T-REX
Official Title
A Randomized Clinical Study Comparing Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation (T-REX Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Luigi Gonzaga Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Reverse T-stenting And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation. 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. Nowadays, no studies compare the Reverse-TAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
Detailed Description
According to DEFINITION criteria, PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularisation (TVR) than Provisional Stenting. 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. However, due to its technical complexity and simultaneous improvement of the Classic Crush technique in the External Minicrush, the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation. 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. The Reverse T-stenting, And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation. 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. Nowadays, studies need to compare the Reverse-TAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Stenosis, Coronary Disease
Keywords
Reverse TAP, External Minicrush, Coronary bifurcation lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
361 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reverse TAP
Arm Type
Active Comparator
Arm Title
External Minicrush
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
Use dedicated two stents technique for treatment of coronary bifurcation stenosis
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF) (Composite of all causes of death, non-fatal TVMI, ischemia-driven target lesion revascularisation (TLR) + Definite or probable ST+ ISR >50% at planned coronary angiography or Coro-TC.
Description
The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).
Time Frame
12-moths
Secondary Outcome Measure Information:
Title
Cardiac death + TVMI + ST
Description
The investigators check mid-term cardiovascular clinical performance between the two techniques.
Time Frame
5-years
Title
Cardiac death + TVMI + ST +TLR
Description
The investigators check mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site.
Time Frame
5-years
Other Pre-specified Outcome Measures:
Title
Acute closure of the side branch and periprocedural-MI.
Description
The investigators check safety of procedural profile between two techniques.
Time Frame
Periprocedural
Title
Intraprocedural ST and periprocedural-MI
Description
The investigators check safety of procedural profile between two techniques.
Time Frame
Periprocedural
Title
Major bleeding (BARC 3 and 5)
Description
The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT.
Time Frame
5-years
Title
Technical success
Description
Defined as TIMI flow 3 and < 30% residual stenosis after PCI on target vessel
Time Frame
Procedural
Title
Procedural success
Description
Defined as technical success with no in-hospital major adverse
Time Frame
Periprocedural
Title
Cross-over between groups
Description
Possibility to switching between two techniques for technical reasons
Time Frame
Periprocedural
Title
Timing of rewiring
Description
Measure of the time spending in a crucial phase of the two techniques
Time Frame
Periprocedural
Title
Number of guide wire used
Description
Number of coronary guidewires to perform the assigned technique.
Time Frame
Periprocedural
Title
Amount of contrast medium used
Description
Total contrast medium used to perform the PCI with the technique assigned
Time Frame
Periprocedural
Title
Procedural time
Description
Total time used to perform the PCI
Time Frame
Periprocedural
Title
Fluoroscopic time
Description
Total fluoroscopic time spending to perform the PCI
Time Frame
Periprocedural
Title
X-rays exposition
Description
Total operators x-rays exposition during the PCI
Time Frame
Periprocedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >18 years old; Patients with an indication of PCI, including Chronic Coronary syndrome (CCS) and Acute Coronary Syndrome (ACS), according to current guidelines recommendations; According to Medina and Definition criteria, patients with at least true and complex coronary lesions involved in coronary bifurcation. Exclusion Criteria: Patients that refused informed consent; Patients without valid vascular access that could make unsafe PCI; Patients with an expected life of less than one year; Patients with scheduled major surgery that required prolonged DAPT interruption; Pregnant patients; Patients with DAPT contraindications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulio Piedimonte, MD
Phone
+393201764900
Email
giulio.piedimonte@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico Cerrato, MD, phD
Email
enrico.cerrato@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulio Piedimonte, MD
Organizational Affiliation
Ospedale degli Infermi di Rivoli (TO)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ciriè Hospital
City
Ciriè
State/Province
Tori O
ZIP/Postal Code
10073
Country
Italy
Facility Name
Ospedale Santa Croce
City
Moncalieri
State/Province
Torino
ZIP/Postal Code
10024
Country
Italy
Facility Name
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
L'Azienda Ospedaliera (AO) S. Croce e Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
City
Turin
ZIP/Postal Code
10100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation

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