Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
NCT ID: NCT06484647
Last Updated: 2024-07-08
Study Results
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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RECRUITING
382 participants
OBSERVATIONAL
2024-06-01
2024-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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T-stenting And Minimal Protrusion
Percutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC).
The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath.
Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily).
The procedural steps of the technique are described below:
* MV stenting
* Distal rewiring towards SB
* Kissing Balloon for opening distal struts towards SB
* SB stent implantation
* Final Kissing Balloon
Percutaneous 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.
External Minicrush
Percutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC).
The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath.
Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily).
The procedural steps of the technique are described below:
* SB stent deployment with protrusion into MB
* Crush the SB stent with a balloon inflating into MB (\>0.5 mm of the SB stent)
* MB stent deployment
* Rewiring
* POT
* KBI
* Final POT technique
Percutaneous 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.
Interventions
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Percutaneous 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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San Luigi Gonzaga Hospital
OTHER
Responsible Party
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Enrico Cerrato
Medical Doctor, MD
Locations
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Rivoli Hospital
Rivoli, Turin, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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001-2024
Identifier Type: -
Identifier Source: org_study_id
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