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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSan Luigi Gonzaga Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Percutaneous Coronary Intervention

    Procedure/Surgery

    Use dedicated two stents technique for treatment of coronary bifurcation stenosis

Treatment groups

361 Participants
are divided into 2 treatment groups
Group A: Reverse TAPActive comparator 1 intervention
Group B: External MinicrushActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Cardiac death + TVMI + ST

The investigators check mid-term cardiovascular clinical performance between the two techniques.

Time frame
5-years
2

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

Other outcomes

1

Acute closure of the side branch and periprocedural-MI.

The investigators check safety of procedural profile between two techniques.

Time frame
Periprocedural
2

Intraprocedural ST and periprocedural-MI

The investigators check safety of procedural profile between two techniques.

Time frame
Periprocedural
3

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
4

Technical success

Defined as TIMI flow 3 and \< 30% residual stenosis after PCI on target vessel

Time frame
Procedural

Sponsors and contacts

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