T-REX: Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Reverse TAP
|
Procedure: Percutaneous Coronary Intervention
Use dedicated two stents technique for treatment of coronary bifurcation stenosis
|
| Active Comparator: External Minicrush
|
Procedure: Percutaneous Coronary Intervention
Use dedicated two stents technique for treatment of coronary bifurcation stenosis
|
Outcome Measures
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. [12-moths]
We will investigate technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).
Secondary Outcome Measures
- Cardiac death + TVMI + ST [5-years]
We will investigate mid-term cardiovascular clinical performance between the two techniques.
- Cardiac death + TVMI + ST +TLR [5-years]
We will investigate mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site.
Other Outcome Measures
- Acute closure of the side branch and periprocedural-MI. [Periprocedural]
We will investigate safety procedural profile between two techniques.
- Intraprocedural ST and periprocedural-MI [Periprocedural]
We will investigate safety procedural profile between two techniques.
- Major bleeding (BARC 3 and 5) [5-years]
We will investigate safety hemorrhagic profile between two techniques in consideration of prolonged DAPT.
- Technical success [Procedural]
defined as TIMI flow 3 and < 30% residual stenosis after PCI on target vessel
- Procedural success [Periprocedural]
Defined as technical success with no in-hospital major adverse
- Cross-over between groups [Periprocedural]
Possibility to switching between two techniques for technical reasons
- Timing of rewiring [Periprocedural]
Measure of the time spending in a crucial phase of the two techniques
- Number of guide wire used [Periprocedural]
Number of coronary guidewires to perform the assigned technique.
- Amount of contrast medium used [Periprocedural]
Total contrast medium used to perform the PCI with the technique assigned
- Procedural time [Periprocedural]
Total time used to perform the PCI
- Fluoroscopic time [Periprocedural]
Total fluoroscopic time spending to perform the PCI
- X-rays exposition [Periprocedural]
Total operators x-rays exposition during the PCI
Eligibility Criteria
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;
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Patients with an expected life of less than one year;
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Patients with scheduled major surgery that required prolonged DAPT interruption;
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Pregnant patients;
-
Patients with DAPT contraindications.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ciriè Hospital | Ciriè | Tori O | Italy | 10073 |
| 2 | Ospedale Santa Croce | Moncalieri | Torino | Italy | 10024 |
| 3 | Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | 15121 | |
| 4 | L'Azienda Ospedaliera (AO) S. Croce e Carle | Cuneo | Italy | 12100 | |
| 5 | Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy | Turin | Italy | 10100 |
Sponsors and Collaborators
- San Luigi Gonzaga Hospital
Investigators
- Principal Investigator: Giulio Piedimonte, MD, Ospedale degli Infermi di Rivoli (TO)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 001-2023