About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Percutaneous Coronary Intervention
Procedure/SurgeryUse dedicated two stents technique for treatment of coronary bifurcation stenosis
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
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.
Other outcomes
Acute closure of the side branch and periprocedural-MI.
The investigators check safety of procedural profile between two techniques.
Intraprocedural ST and periprocedural-MI
The investigators check safety of procedural profile between two techniques.
Major bleeding (BARC 3 and 5)
The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT.
Technical success
Defined as TIMI flow 3 and \< 30% residual stenosis after PCI on target vessel
Sponsors and contacts
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