Percutaneous coronary intervention
ProcedureUse dedicated two stents technique for treatment of coronary bifurcation stenosis
NCT Number: NCT05782738
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Ciriè Hospital, Cirié, Tori O, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use dedicated two stents technique for treatment of coronary bifurcation stenosis
Time frame: 12-moths
The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).
Time frame: 5-years
The investigators check mid-term cardiovascular clinical performance between the two techniques.
Time frame: 5-years
The investigators check mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site.
Time frame: Periprocedural
The investigators check safety of procedural profile between two techniques.
Time frame: Periprocedural
The investigators check safety of procedural profile between two techniques.
Time frame: 5-years
The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT.
Time frame: Procedural
Defined as TIMI flow 3 and < 30% residual stenosis after PCI on target vessel
Time frame: Periprocedural
Defined as technical success with no in-hospital major adverse
Time frame: Periprocedural
Possibility to switching between two techniques for technical reasons
Time frame: Periprocedural
Measure of the time spending in a crucial phase of the two techniques
Time frame: Periprocedural
Number of coronary guidewires to perform the assigned technique.
Time frame: Periprocedural
Total contrast medium used to perform the PCI with the technique assigned
Time frame: Periprocedural
Total time used to perform the PCI
Time frame: Periprocedural
Total fluoroscopic time spending to perform the PCI
Time frame: Periprocedural
Total operators x-rays exposition during the PCI
Contact information is provided by the study sponsor or research team.
Enrico Cerrato, MD, phD
CONTACT
Giulio Piedimonte, MD
CONTACT
San Luigi Gonzaga Hospital
Other
A Randomized Clinical Study Comparing Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation (T-REX Trial)
Acronym: T-REX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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