OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs

NCT04674475 | Unknown DMC

• 1 other identifier: SpanishSC
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Pressure guidewire, optimal coherence tomography DEVICE

Pressure guidewire, optimal coherence tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Society of Cardiology: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Raul Moreno, MD, PhD

CONTACT

917277355; raulmorenog@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Cardiology, Hospital La Paz, Madrid, Spain

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: May 3, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 16, 2023
• Last Updated: December 19, 2020

Record last verified: 2020-12