An interventional study of Percutaneous Coronary Intervention in Coronary Artery Disease, Coronary Stenosis and Coronary Disease, sponsored by San Luigi Gonzaga Hospital. Not yet recruiting at 5 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by San Luigi Gonzaga Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Procedure: Percutaneous Coronary Intervention
Procedure: Percutaneous Coronary Intervention
Use dedicated two stents technique for treatment of coronary bifurcation stenosis
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).
Time frame: 12-moths
Cardiac death + TVMI + ST
The investigators check mid-term cardiovascular clinical performance between the two techniques.
Time frame: 5-years
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.
Time frame: 5-years
Acute closure of the side branch and periprocedural-MI.
The investigators check safety of procedural profile between two techniques.
Time frame: Periprocedural
Intraprocedural ST and periprocedural-MI
The investigators check safety of procedural profile between two techniques.
Time frame: Periprocedural
Major bleeding (BARC 3 and 5)
The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT.
Time frame: 5-years
Technical success
Defined as TIMI flow 3 and \< 30% residual stenosis after PCI on target vessel
Time frame: Procedural
Procedural success
Defined as technical success with no in-hospital major adverse
Time frame: Periprocedural
Cross-over between groups
Possibility to switching between two techniques for technical reasons
Time frame: Periprocedural
Timing of rewiring
Measure of the time spending in a crucial phase of the two techniques
Time frame: Periprocedural
Number of guide wire used
Number of coronary guidewires to perform the assigned technique.
Time frame: Periprocedural
Amount of contrast medium used
Total contrast medium used to perform the PCI with the technique assigned
Time frame: Periprocedural
Procedural time
Total time used to perform the PCI
Time frame: Periprocedural
Fluoroscopic time
Total fluoroscopic time spending to perform the PCI
Time frame: Periprocedural
X-rays exposition
Total operators x-rays exposition during the PCI
Time frame: Periprocedural
Plan to share: No
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San Luigi Gonzaga Hospital