Coronary Artery DiseaseOPTI-XIENCENCT04674475
OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs
An observational study of Coronary Artery Disease, run by Spanish Society of Cardiology.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Pressure guidewire, optimal coherence tomography
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2021to 16 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Pressure guidewire, optimal coherence tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure guidewire, optimal coherence tomographyDevice
Pressure guidewire, optimal coherence tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start3 May 2021 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion16 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Moreno, MD, PhD, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674475
- Sponsor's protocol ID
- SpanishSC
- Acronym
- OPTI-XIENCE
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moreno R, Baptista SB, Valencia J, Gomez-Menchero A, Bouisset F, Ruiz-Arroyo JR, Bento A, Besutti M, Jimenez-Valero S, Rivero-Santana B, Olhmann P, Santos M, Vaquerizo B, Cuissetm T, Lemoine J, Pinar E, Fiarresga A, Urbano C, Marliere S, Braga C, Amat-Santos I, Morgado G, Sarnago F, Telleria M, Van Belle E, Diaz-Fernandez J, Borrego JC, Amabile N, Meneveau N. OPTImized coronary interventions eXplaIn the bEst cliNical outcomEs (OPTI-XIENCE) study. Rationale and study design. Cardiovasc Revasc Med. 2024 Feb;59:93-98. doi: 10.1016/j.carrev.2023.08.011. Epub 2023 Sep 4.
PubMed 37723011
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs
- ClinicalTrials.gov ID
- NCT04674475
- Acronym / sponsor ID
- OPTI-XIENCE / SpanishSC
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Study start
- 3 May 2021 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 16 Jun 2023 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure guidewire, optimal coherence tomographyPressure guidewire, optimal coherence tomography | Device | – |
Primary outcome
Target lesion failure
Time frame: 1 year
composite of ischemia-driven target lesion revascularization, myocardial infarction (MI) related to the target vessel, or cardiac death related to the target vessel.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 37723011Moreno R, Baptista SB, Valencia J, Gomez-Menchero A, Bouisset F, Ruiz-Arroyo JR, Bento A, Besutti M, Jimenez-Valero S, Rivero-Santana B, Olhmann P, Santos M, Vaquerizo B, Cuissetm T, Lemoine J, Pinar E, Fiarresga A, Urbano C, Marliere S, Braga C, Amat-Santos I, Morgado G, Sarnago F, Telleria M, Van Belle E, Diaz-Fernandez J, Borrego JC, Amabile N, Meneveau N. OPTImized coronary interventions eXplaIn the bEst cliNical outcomEs (OPTI-XIENCE) study. Rationale and study design. Cardiovasc Revasc Med. 2024 Feb;59:93-98. doi: 10.1016/j.carrev.2023.08.011. Epub 2023 Sep 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Spanish Society of Cardiology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raul Moreno, MD, PhD (917277355, raulmorenog@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.