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OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs

NCT ID: NCT04674475

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-03

Study Completion Date

2023-06-16

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Pressure guidewire, optimal coherence tomography

Pressure guidewire, optimal coherence tomography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Society of Cardiology

OTHER

Sponsor Role lead

Responsible Party

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Raul Moreno, MD, PhD

Director of Interventional Cardiology, Hospital La Paz, Madrid, Spain

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Raul Moreno, MD, PhD

Role: CONTACT

Phone: 917277355

Email: [email protected]

Other Identifiers

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SpanishSC

Identifier Type: -

Identifier Source: org_study_id