Acute Coronary Syndrome, Chronic Coronary Syndrome, Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
Percutaneous Coronary Intervention (PCI), Coronary Artery Disease (CAD), Coronary Bifurcation Lesion (CBL)
Brief summary
Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
Detailed description
1. According to DEFINITION criteria, PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization (TVR) compared to Provisional Stenting 2. 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. 3. However, due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush, it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation 4. 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. 5. The T-stenting And Minimal Protrusion (TAP) is a two-stent technique described to treat coronary bifurcation after provisional treating. 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. 6. Nowadays, no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown. 7. The issue's importance is highlighted by higher rates of stent thrombosis (ST) and in-stent restenosis (ISR) of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8. 8. Consequently, investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR.
Interventions
PROCEDUREPercutaneous Coronary Intervention
Percutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation. The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique.
Sponsors
San Luigi Gonzaga Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients \>18 years of age * Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina) * Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1
Exclusion criteria
* Patients who do not want or cannot sign the informed consent for the procedure. * Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe. * Patients with a life expectancy of \<1 year. * Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy. * Pregnant women. * Patients who cannot take antiplatelet therapy for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 5-years | a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis (ST) | 5-years | Thrombosis of the stent after PCI |
| Intrastent-restenosis (ISR) | 5-years | Intrastent restenosis with \>50% of the stent diameter |
| Target Vessel MI (TVMI) | 5-years | Target vessel myocardial infarction at follow-up |
Countries
Italy
Contacts
Primary ContactGiulio Piedimonte, MD
Backup ContactEnrico Cerrato, MD, PhD
Outcome results
None listed