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Clinical Trials in Italy / NCT05782738
Starting soon Not applicable

Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation

NCT05782738 · tracked via the Priya Life Science Italy tracker
Sponsor
San Luigi Gonzaga Hospital
Phase
Not applicable
Started
2023-06-01
Last updated
2023-04-19

Condition(s) studied

Coronary Artery DiseaseCoronary StenosisCoronary Disease

Investigational drug(s) / intervention(s)

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention: Use dedicated two stents technique for treatment of coronary bifurcation stenosis

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients \>18 years old; * Patients with an indication of PCI, including Chronic Coronary syndrome (CCS) and Acute Coronary Syndrome (ACS), according to current guidelines recommendations; According to Medina and Definition criteria, patients with at least true and complex coronary lesions involved in coronary bifurcation. Exclusion Criteria: * Patients that refused informed consent; * Patients without valid vascular access that could make unsafe PCI; * Patients with an expected life of less than one year; * Patients with scheduled major surgery that required prolonged DAPT interruption; * Pregnant patients; * Patients with DAPT contraindications.

Primary outcome measure(s)

  • 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. — 12-moths
    The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).

Trial sites (5)

FacilityCityRegionStatus
Ciriè Hospital Cirié Tori O
Ospedale Santa Croce Moncalieri Torino
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo Alessandria Italy
L'Azienda Ospedaliera (AO) S. Croce e Carle Cuneo Italy
Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy Turin Italy

More San Luigi Gonzaga Hospital trials in Italy

Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry Enrolling by invitation
AGECTO Study: PCI vs. Optimal Medical Therapy for CTO in the Octogenarian Patients Active, not recruiting
Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis Recruiting
Anastomotic Leakage After Right Hemicolectomy for Cancer, a Prospective Multicenter Study of SICO-CC Network Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05782738 on ClinicalTrials.gov ↗ ← All trials in Italy