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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reverse TAP | Active Comparator |
| |
| External Minicrush | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Procedure | Use dedicated two stents technique for treatment of coronary bifurcation stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12-moths |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death + TVMI + ST | The investigators check mid-term cardiovascular clinical performance between the two techniques. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute closure of the side branch and periprocedural-MI. | The investigators check safety of procedural profile between two techniques. | Periprocedural |
| Intraprocedural ST and periprocedural-MI | The investigators check safety of procedural profile between two techniques. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulio Piedimonte, MD | Contact | +393201764900 | giulio.piedimonte@gmail.com | |
| Enrico Cerrato, MD, phD | Contact | enrico.cerrato@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Giulio Piedimonte, MD | Ospedale degli Infermi di Rivoli (TO) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciriè Hospital | Cirié | Tori O | 10073 | Italy | ||
| Ospedale Santa Croce |
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| 5-years |
| Periprocedural |
| Major bleeding (BARC 3 and 5) | The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT. | 5-years |
| Technical success | Defined as TIMI flow 3 and < 30% residual stenosis after PCI on target vessel | Procedural |
| Procedural success | Defined as technical success with no in-hospital major adverse | Periprocedural |
| Cross-over between groups | Possibility to switching between two techniques for technical reasons | Periprocedural |
| Timing of rewiring | Measure of the time spending in a crucial phase of the two techniques | Periprocedural |
| Number of guide wire used | Number of coronary guidewires to perform the assigned technique. | Periprocedural |
| Amount of contrast medium used | Total contrast medium used to perform the PCI with the technique assigned | Periprocedural |
| Procedural time | Total time used to perform the PCI | Periprocedural |
| Fluoroscopic time | Total fluoroscopic time spending to perform the PCI | Periprocedural |
| X-rays exposition | Total operators x-rays exposition during the PCI | Periprocedural |
| Moncalieri |
| Torino |
| 10024 |
| Italy |
| Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Alessandria | 15121 | Italy |
| L'Azienda Ospedaliera (AO) S. Croce e Carle | Cuneo | 12100 | Italy |
| Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy | Turin | 10100 | Italy |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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