Multi Vessel Coronary Artery DiseasePRESENTNCT05230446
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
A study testing PCI with OCT guidance in people with Multi Vessel Coronary Artery Disease and Non-ST Elevation Myocardial Infarction, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multi Vessel Coronary Artery Disease, Non-ST Elevation Myocardial Infarction, Unstable Angina
- What is being tested?
- PCI with OCT guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Nov 2021to 18 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, ≤85 years
- The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
- Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Resolute Onyx (Zotarolimus-Eluting stent) system.
- The patient is willing and able to cooperate with study procedures and required follow up visits
- The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization
Who cannot join
- Age <18 years and > 85 years.
- Single coronary vessel disease.
- No left anterior descending lesion.
- Patients in cardiogenic shock.
- Patients with STEMI.
- Presence of a chronic total occlusion (CTO) defined as coronary lesion with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial angiography present for more than or equal to 3 months.
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- Left main coronary artery disease
- Patients who cannot give informed consent or have a life expectancy of less than 12 months.
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors.
- Patients with an extreme LAD tortuosity imparing OCT catheter advancement
- Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint. The patient may only be enrolled once in the PRESENT study.
- Previous coronary artery bypass grafting (CABG).
- Patient requiring additional cardiac surgery within 6 months.
- Women of childbearing potential who do not have a negative pregnancy test result within 7 days before the procedure, women who are known to be pregnant, or who are breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hala Kakar, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
Roberto Diletti, MD, PhD, 0031634767375, r.diletti@erasmusmc.nl
About this study
This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).
Read the detailed description
The PRESENT is an investigator-initiated, prospective, multicenter, non-randomized, single arm, OPG study. The objective performance goal is based on past results of CABG namely a rate of 7% MACCE at 1-year follow-up. All patients with multivessel disease without chronic total occlusion (CTO) and accepted for PCI are eligible for inclusion
Primary endpoint The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.
Secondary endpoint
- Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization at 30 days, 2, and 5 years post intervention.
- All-cause mortality at 30 days, 1, 2, and 5 years
- Myocardial Infarction at 30 days, 1, 2, and 5 years
- Any revascularization at 30 days, 1, 2, and 5 years
- Stroke at 30 days, 1, 2, and 5 years
- Major bleeding at 30 days and 12 months
- Need for renal replacement therapy at 30 days
- Conditions
- Multi Vessel Coronary Artery Disease, Non-ST Elevation Myocardial Infarction, Unstable Angina, Stable Angina, Coronary Artery Disease, Percutaneous Coronary Intervention
- Being tested
- PCI with OCT guidance
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Angina, Unstable, Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI with OCT guidanceDevice
Procedure will be optimize using pre-and post-stent OCT imaging, to improve the accuracy of stent placement and reduce geographic miss, but also to prevent malapposition of the stent and to discover dissections.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention | Other | Interventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results Receives: Device: PCI with OCT guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE- 1 year
The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.
Measured: 1 year
Secondary outcomes (7)
MACCE
Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization
Measured: 30 days, 2, and 5 years post intervention
All-cause mortality
All-cause mortality
Measured: 30 days, 1, 2, and 5 years
Myocardial Infarction
Myocardial Infarction
Measured: 30 days, 1, 2, and 5 years
Any revascularization
Any revascularization
Measured: 30 days, 1, 2, and 5 years
Stroke
Stroke
Measured: 30 days, 1, 2, and 5 years
Major bleeding
Major bleeding according to the ARC criteria
Measured: 30 days and 12 months
Renal replacement therapy
Need for renal replacement therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start18 Nov 2021
- Primary completion18 Nov 2023 (estimated)
- Study completion18 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi Vessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 609 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Diletti, Erasmus Medical Center
- Investigators
- Roberto Diletti, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230446
- Sponsor's protocol ID
- NL76556.078.21
- Acronym
- PRESENT
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
- ClinicalTrials.gov ID
- NCT05230446
- Acronym / sponsor ID
- PRESENT / NL76556.078.21
- Conditions
- Multi Vessel Coronary Artery Disease, Non-ST Elevation Myocardial Infarction, Unstable Angina, Stable Angina, Coronary Artery Disease, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 609 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 18 Nov 2023 (estimated)
- Study completion
- 18 Nov 2027 (estimated)
- First posted
- 9 Feb 2022 (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.
This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).
Detailed description
The PRESENT is an investigator-initiated, prospective, multicenter, non-randomized, single arm, OPG study. The objective performance goal is based on past results of CABG namely a rate of 7% MACCE at 1-year follow-up. All patients with multivessel disease without chronic total occlusion (CTO) and accepted for PCI are eligible for inclusion
Primary endpoint The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.
Secondary endpoint
- Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization at 30 days, 2, and 5 years post intervention.
- All-cause mortality at 30 days, 1, 2, and 5 years
- Myocardial Infarction at 30 days, 1, 2, and 5 years
- Any revascularization at 30 days, 1, 2, and 5 years
- Stroke at 30 days, 1, 2, and 5 years
- Major bleeding at 30 days and 12 months
- Need for renal replacement therapy at 30 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention | Other | Device: PCI with OCT guidanceInterventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years, ≤85 years
- The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
- Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Resolute Onyx (Zotarolimus-Eluting stent) system.
- The patient is willing and able to cooperate with study procedures and required follow up visits
- The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization
Key exclusion criteria (14 listed)
- Age <18 years and > 85 years.
- Single coronary vessel disease.
- No left anterior descending lesion.
- Patients in cardiogenic shock.
- Patients with STEMI.
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 |
|---|---|---|
| PCI with OCT guidanceProcedure will be optimize using pre-and post-stent OCT imaging, to improve the accuracy of stent placement and reduce geographic miss, but also to prevent malapposition of the stent and to discover dissections. | Device | Percutaneous Coronary Intervention |
Primary outcome
MACCE- 1 year
Time frame: 1 year
The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.
7 secondary outcomes
MACCE
Time frame: 30 days, 2, and 5 years post intervention
All-cause mortality
Time frame: 30 days, 1, 2, and 5 years
Myocardial Infarction
Time frame: 30 days, 1, 2, and 5 years
Any revascularization
Time frame: 30 days, 1, 2, and 5 years
Stroke
Time frame: 30 days, 1, 2, and 5 years
Major bleeding
Time frame: 30 days and 12 months
Renal replacement therapy
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
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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.
Hala Kakar, MD contact
Roberto Diletti, MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI with OCT guidance in people with Multi Vessel Coronary Artery Disease and Non-ST Elevation Myocardial Infarction, run by Erasmus Medical Center at 1 site in Netherlands.
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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Diletti, MD PhD (+31 (0)10 70 352 60, r.diletti@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE- 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2022.