NCT04144881Completed
Angiographic Control Vs. Ischemia-driven Management of Patients Treated with PCI on Left Main with Drug-eluting Stents
Angiographic Control Vs. Ischemia-driven Management of Patients Undergoing Percutaneous Revascularization of the Unprotected Left Main Coronary Artery with Second-generation Drug Eluting Stents: the PULSE Trial
Source: ClinicalTrials.gov · Last updated 4 Nov 2024
Brief summary (registry, in English)
The present study aims to compare a planned angiographic control (PAC) follow-up strategy vs. conservative management for patients treated with drug-eluting stents on unprotected left main artery in a prospective, randomized setting. PAC will be performed by coronary computed tomography (CCT), to avoid the limitations of the invasive coronary angiography which is usually employed to perform PAC. The superiority of a PAC-based approach will be tested on a hard clinical end-point such as the incidence of major adverse cardiovascular events. The investigators will also assess the performance of CCT as a tool to perform PAC.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 606 (actual)
- First submitted
- 28 Oct 2019
- Start date
- 11 Oct 2019
- Primary completion date
- 3 Sept 2024
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Diseases
- Coronary artery disease
- NCT number
- NCT04144881
What you commit to
- Study type: Interventional
- Participants enrolled: 606
- From 11 Oct 2019 to the primary completion date, 3 Sept 2024
- 3 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.
Other
- Cardiogenic shock
- Refusal or inability to provide informed consent
Who the study is looking for
- Patients with ULM disease treated by PCI with DES-II with the following inclusion criteria:
- Age 18-85.
- Glomerular filtration rate \> 30 ml/min Indication to percutaneous revascularization of ULM according to Syntax score (\< 33) or, in dubious cases, after Heart Team evaluation
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria di Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Ospedale San Luigi Gonzaga, Orbassano Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| AOU Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.