Coronary Artery Disease, Coronary Disease, Coronary Stenosis
Conditions
Keywords
Reverse TAP, External Minicrush, Coronary bifurcation lesion
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.
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.
Interventions
PROCEDUREPercutaneous Coronary Intervention
Use dedicated two stents technique for treatment of coronary bifurcation stenosis
Sponsors
San Luigi Gonzaga Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death + TVMI + ST | 5-years | The investigators check mid-term cardiovascular clinical performance between the two techniques. |
| Cardiac death + TVMI + ST +TLR | 5-years | The investigators check mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Acute closure of the side branch and periprocedural-MI. | Periprocedural | The investigators check safety of procedural profile between two techniques. |
| 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 |
| Number of guide wire used | Periprocedural | Number of coronary guidewires to perform the assigned technique. |
| Intraprocedural ST and periprocedural-MI | Periprocedural | The investigators check safety of procedural profile between two techniques. |
| Major bleeding (BARC 3 and 5) | 5-years | The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT. |
Countries
Italy
Contacts
Primary ContactGiulio Piedimonte, MD
Backup ContactEnrico Cerrato, MD, phD
Outcome results
None listed