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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2029-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Coronary Stenosis Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Reverse TAP

Group Type ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Use dedicated two stents technique for treatment of coronary bifurcation stenosis

External Minicrush

Group Type ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Use dedicated two stents technique for treatment of coronary bifurcation stenosis

Interventions

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Percutaneous Coronary Intervention

Use dedicated two stents technique for treatment of coronary bifurcation stenosis

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No