Clinical trial NCT04674475: OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs
Official title: OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective observational multicentric international study with a follow-up of 12 months, including 1.000 patients treated with coblat-chromium everolimus-eluting coronary stents and high risk of events 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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Target lesion failure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
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