NCT05782738Not yet recruiting
Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
A Randomized Clinical Study Comparing Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation (T-REX Trial)
Source: ClinicalTrials.gov · Last updated 19 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 361 (estimated)
- First submitted
- 11 Mar 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- San Luigi Gonzaga Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05782738
What you commit to
- Study type: Interventional
- Planned participants: 361
- From 1 Jun 2023 to the primary completion date, 1 Jun 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with scheduled major surgery that required prolonged DAPT interruption;
Other
- 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;
- Pregnant patients;
- Patients with DAPT contraindications.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo Coordinator of this site? Confirm its status | Alessandria | Italy | Unknown status |
| Ciriè Hospital Coordinator of this site? Confirm its status | Cirié | Italy | Unknown status |
| L'Azienda Ospedaliera (AO) S. Croce e Carle Coordinator of this site? Confirm its status | Cuneo | Italy | Unknown status |
| Ospedale Santa Croce Coordinator of this site? Confirm its status | Moncalieri | Italy | Unknown status |
| Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy Coordinator of this site? Confirm its status | Turin | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.