An interventional study of Percutaneous Coronary Intervention in Coronary Artery Disease, Coronary Stenosis and Coronary Disease, sponsored by San Luigi Gonzaga Hospital. Not yet recruiting at 5 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by San Luigi Gonzaga Hospital · Not applicable, Interventional, and Treatment
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 361 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →San Luigi Gonzaga Hospital is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Percutaneous Coronary Intervention
Procedure: Percutaneous Coronary Intervention
Use dedicated two stents technique for treatment of coronary bifurcation stenosis
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.
The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).
Time frame: 12-moths
Cardiac death + TVMI + ST
The investigators check mid-term cardiovascular clinical performance between the two techniques.
Time frame: 5-years
Cardiac death + TVMI + ST +TLR
The investigators check mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site.
Time frame: 5-years
Acute closure of the side branch and periprocedural-MI.
The investigators check safety of procedural profile between two techniques.
Time frame: Periprocedural
Intraprocedural ST and periprocedural-MI
The investigators check safety of procedural profile between two techniques.
Time frame: Periprocedural
Major bleeding (BARC 3 and 5)
The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT.
Time frame: 5-years
Technical success
Defined as TIMI flow 3 and \< 30% residual stenosis after PCI on target vessel
Time frame: Procedural
Procedural success
Defined as technical success with no in-hospital major adverse
Time frame: Periprocedural
Cross-over between groups
Possibility to switching between two techniques for technical reasons
Time frame: Periprocedural
Timing of rewiring
Measure of the time spending in a crucial phase of the two techniques
Time frame: Periprocedural
Number of guide wire used
Number of coronary guidewires to perform the assigned technique.
Time frame: Periprocedural
Amount of contrast medium used
Total contrast medium used to perform the PCI with the technique assigned
Time frame: Periprocedural
Procedural time
Total time used to perform the PCI
Time frame: Periprocedural
Fluoroscopic time
Total fluoroscopic time spending to perform the PCI
Time frame: Periprocedural
X-rays exposition
Total operators x-rays exposition during the PCI
Time frame: Periprocedural
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2023; primary completion for Jun 2026, 36 months later.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 36 months is close to that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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San Luigi Gonzaga Hospital