OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs

Coronary Artery Disease Clinical Trial

— OPTI-XIENCE  

Official title:

OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04674475
• Other study ID #: SpanishSC
• Status: Not yet recruiting
• Start date: May 3, 2021
• Est. completion date: June 16, 2023

Study information

• Verified date: December 2020
• Source: Spanish Society of Cardiology
• Contact: Raul Moreno, MD, PhD
• Phone: 917277355
• Email: raulmorenog[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hypothesis: the clinical outcome of patients with indication of PCI and coronary stent implantation that are at high risk of events can be improved with a widespread use of intra-coronary tools that allow a PCI optimization (i.e. functional assessment by pressure guidewire and intra-coronary imaging techniques).

Objective: to evaluate whether the use of pressure guidewire and intra-coronary imaging techniques (mainly optimal coherence tomography) in patients at high risk of events undergoing coronary angiography for myocardial revascularization is associated with an improved clinical outcome in comparison with patient with angiographic alone guided cobalt-chromium everolimus-eluting coronary stenting.

Methods: Prospective observational multicentric international study with a follow-up of 12 months, including 1.000 patients in 40 sites located in 3 European countries (Spain, France, and Portugal). The control group will be comprised by a similar number of matched patients included in the "extended-risk" cohort of the XIENCE V USA study. PCI will be performed following local standard protocols and accordingly to the physician criteria. The use of pressure guidewire will be recommended according to the current guidelines, in patients with angiographically intermediate lesions and in those with multivessel disease. The use of OCT will be strongly recommended, as patients included will be considered to be at high risk of events, accordingly to the current recommendations. The primary endpoint will be target lesion failure (TLF) at 1 year.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: June 16, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least one of the following high-risk characteristics: lesion length > 28 mm; reference vessel diameter < 2.5 mm or > 4.25 mm; chronic total occlusion; bifurcation with side branch = 2 mm; ostial lesion; left main; in-stent restenosis; more than 2 lesions stented in the save vessel; more than 2 vessels treated; acute myocardial infarction; renal insufficiency; ejection fraction < 30%; or staged procedure. There will be no protocol exclusions on the basis of clinical features or angiographic criteria. The indication of using CCEES will be determined by the implanting physician.

• Informed consent signed

Exclusion Criteria:

• Patients whose survival is expected to be lower than 1 year at hospital discharge.

• Patients not willing to participate

• Patient not simultaneously participating in any interventional study

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Pressure guidewire, optimal coherence tomography
Pressure guidewire, optimal coherence tomography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	composite of ischemia-driven target lesion revascularization, myocardial infarction (MI) related to the target vessel, or cardiac death related to the target vessel.	1 year