Myocardial InfarctionHONESTNCT03016624
Coronary Artery Healing and Bioresorbable Scaffold
A study testing OCT guided PCI and Angiography guided PCI in people with Myocardial Infarction and Coronary Artery Disease, run by Odense University Hospital at 1 site in Denmark.
Trial summary
To compare coronary healing after optical coherence tomography guided versus conventionally angiography guided percutaneous coronary intervention with the Magmaris bioresorbable scaffold. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- OCT guided PCI and Angiography guided PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to Sep 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with NSTEMI undergoing subacute PCI in native vessels and to be treated with one or more drug eluting stents in coronary arteries due to a visually assessed significant culprit lesion with > 50% of coronary stenosis at the catheterization laboratory in Odense.
Who cannot join
- Patients participating in other randomized stent studies.
- Expected survival < 1 year.
- Allergy to aspirin, ticagrelor, clopidogrel and prasugrel.
- Allergy to Sirolimus.
- Aorta-ostial lesions (cannot be cleared with flush by OCT).
- Serum creatinine > 150 ug/L due to the required amount of X-ray contrast by OCT.
- Twisted coronary vessels where the PCI-operator estimates that the introduction of an OCT and / or NIRS catheter will not be possible or will be associated with increased risk.
- Lesion length > 28 mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Artery Healing Process After BiOresorbable Scaffold iN PatiEnts With Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
To compare coronary healing after optical coherence tomography guided versus conventionally angiography guided percutaneous coronary intervention with the Magmaris bioresorbable scaffold.
Read the detailed description
BACKGROUND:
Bioresorbable scaffolds (BRS) represent a novel approach during percutaneous coronary intervention (PCI), which provides transient vessel support with drug-delivery capability without the long-term limitations (very late stent thrombosis) of the metallic drug-eluting stents. Patients with Non-ST-segment elevation myocardial infarction (NSTEMI) often feature thrombus-rich lesions with large necrotic core, which may be associated with delayed arterial healing and impaired stent-related outcomes. Besides clinical indication and underlying plaque morphology, sufficient and potent strut coverage depends on several additional factors (patient characteristics, stent type and procedural factors). Particularly, acute incomplete stent apposition is a strong procedural risk factor for later deficient neointimal coverage. Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality, that enables in-vivo evaluation of the immediate stenting result, and the vascular healing pattern including strut coverage at follow-up.
AIM:
The objective of this study is to investigate if OCT-guided Magmaris BRS implantation in patients with NSTEMI can improve the coronary arterial healing at 6 months compared to routine angiographic guidance only. Further to investigate if the plaque composition/lipid content will influence on the vascular healing.
METHOD:
The study is designed as a prospective, randomized trial. After pre-dilation, patients will be randomly assigned to either: (1) OCT-guided PCI, or (2) angio-guided PCI with Magmaris BRS implantation. In the OCT-guided group, OCT will be used for vessel and BRS sizing. After Magmaris BRS implantation the result will be controlled with OCT and: 1) BRS under expansion and/or, 2) strut malapposition and/or, 3) edge dissection- and/or 4) residual stenosis at the distal and/or proximal reference segment(s) that may require further intervention. A final OCT will be performed in case of re-intervention.
In the angio-guided group an OCT will be performed only after angiography final and acceptable result.
A follow-up OCT will be performed after 6 months in all patients to assess the vascular healing and a vasomotor test will be performed in half of the patients. After 12 months the dynamic changes in vascular healing will be assessed in the first enrolled half of the patients.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- OCT guided PCI, Angiography guided PCI
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT guided PCIDevice
oct guided
Angiography guided PCIDevice
angio guided
| Study group | Role | What they receive |
|---|---|---|
| OCT guided Magmaris implantation | Active comparator | Percutaneous coronary intervention with Magmaris Receives: Device: OCT guided PCI |
| Angiography guided Magmaris implantation | Active comparator | Percutaneous coronary intervention with Magmaris Receives: Device: Angiography guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery healing score
The primary endpoint is coronary artery healing score assessed by OCT Healing score is a weighted index that combines the following components: Uncovered scaffold struts, Uncovered "jailed" and acquired or persistent malapposed struts, Persistent mal apposition, Acquired mal apposition, Maximum neointimal growth and Accumulated extra stent lumen
Measured: 6 months
Secondary outcomes (2)
Coronary artery healing
Secondary endpoints are all individual components of coronary artery healing score
Measured: 6 and 12 months.
Coronary artery healing
Vasomotion at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion29 Aug 2019
- Study completionSep 2024 (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 Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Oliver Fallesen, Odense University Hospital
- Investigators
- Lisette O Jensen, MD, DMSci, PhD, Professor, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016624
- Sponsor's protocol ID
- S-20150133
- Acronym
- HONEST
- Status last verified
- Feb 2021
- First submitted
- 9 Jan 2017
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fallesen CO, Antonsen L, Maehara A, Noori M, Hougaard M, Hansen KN, Ellert J, Ahlehoff O, Veien KT, Lassen JF, Junker AB, Hansen HS, Jensen LO. Optical Coherence Tomography- Versus Angiography-Guided Magnesium Bioresorbable Scaffold Implantation in NSTEMI Patients. Cardiovasc Revasc Med. 2022 Jul;40:101-110. doi: 10.1016/j.carrev.2021.12.003. Epub 2021 Dec 15.
PubMed 34949544
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Healing Process After BiOresorbable Scaffold iN PatiEnts With Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
- ClinicalTrials.gov ID
- NCT03016624
- Acronym / sponsor ID
- HONEST / S-20150133
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- 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.
To compare coronary healing after optical coherence tomography guided versus conventionally angiography guided percutaneous coronary intervention with the Magmaris bioresorbable scaffold.
Detailed description
BACKGROUND:
Bioresorbable scaffolds (BRS) represent a novel approach during percutaneous coronary intervention (PCI), which provides transient vessel support with drug-delivery capability without the long-term limitations (very late stent thrombosis) of the metallic drug-eluting stents. Patients with Non-ST-segment elevation myocardial infarction (NSTEMI) often feature thrombus-rich lesions with large necrotic core, which may be associated with delayed arterial healing and impaired stent-related outcomes. Besides clinical indication and underlying plaque morphology, sufficient and potent strut coverage depends on several additional factors (patient characteristics, stent type and procedural factors). Particularly, acute incomplete stent apposition is a strong procedural risk factor for later deficient neointimal coverage. Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality, that enables in-vivo evaluation of the immediate stenting result, and the vascular healing pattern including strut coverage at follow-up.
AIM:
The objective of this study is to investigate if OCT-guided Magmaris BRS implantation in patients with NSTEMI can improve the coronary arterial healing at 6 months compared to routine angiographic guidance only. Further to investigate if the plaque composition/lipid content will influence on the vascular healing.
METHOD:
The study is designed as a prospective, randomized trial. After pre-dilation, patients will be randomly assigned to either: (1) OCT-guided PCI, or (2) angio-guided PCI with Magmaris BRS implantation. In the OCT-guided group, OCT will be used for vessel and BRS sizing. After Magmaris BRS implantation the result will be controlled with OCT and: 1) BRS under expansion and/or, 2) strut malapposition and/or, 3) edge dissection- and/or 4) residual stenosis at the distal and/or proximal reference segment(s) that may require further intervention. A final OCT will be performed in case of re-intervention.
In the angio-guided group an OCT will be performed only after angiography final and acceptable result.
A follow-up OCT will be performed after 6 months in all patients to assess the vascular healing and a vasomotor test will be performed in half of the patients. After 12 months the dynamic changes in vascular healing will be assessed in the first enrolled half of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT guided Magmaris implantation | Active comparator | Device: OCT guided PCIPercutaneous coronary intervention with Magmaris |
| Angiography guided Magmaris implantation | Active comparator | Device: Angiography guided PCIPercutaneous coronary intervention with Magmaris |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with NSTEMI undergoing subacute PCI in native vessels and to be treated with one or more drug eluting stents in coronary arteries due to a visually assessed significant culprit lesion with > 50% of coronary stenosis at the catheterization laboratory in Odense.
Key exclusion criteria (8 listed)
- Patients participating in other randomized stent studies.
- Expected survival < 1 year.
- Allergy to aspirin, ticagrelor, clopidogrel and prasugrel.
- Allergy to Sirolimus.
- Aorta-ostial lesions (cannot be cleared with flush by OCT).
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 |
|---|---|---|
| OCT guided PCIoct guided | Device | OCT guided Magmaris implantation |
| Angiography guided PCIangio guided | Device | Angiography guided Magmaris implantation |
Primary outcome
Coronary artery healing score
Time frame: 6 months
The primary endpoint is coronary artery healing score assessed by OCT Healing score is a weighted index that combines the following components: Uncovered scaffold struts, Uncovered "jailed" and acquired or persistent malapposed struts, Persistent mal apposition, Acquired mal apposition, Maximum neointimal growth and Accumulated extra stent lumen
2 secondary outcomes
Coronary artery healing
Time frame: 6 and 12 months.
Coronary artery healing
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 34949544Fallesen CO, Antonsen L, Maehara A, Noori M, Hougaard M, Hansen KN, Ellert J, Ahlehoff O, Veien KT, Lassen JF, Junker AB, Hansen HS, Jensen LO. Optical Coherence Tomography- Versus Angiography-Guided Magnesium Bioresorbable Scaffold Implantation in NSTEMI Patients. Cardiovasc Revasc Med. 2022 Jul;40:101-110. doi: 10.1016/j.carrev.2021.12.003. Epub 2021 Dec 15.
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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.
Lisette O Jensen, MD, DMSci, PhD, Professor study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT guided PCI and Angiography guided PCI in people with Myocardial Infarction and Coronary Artery Disease, run by Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 8 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 2 Mar 2021. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery healing score (time frame: 6 months). 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 NCT03016624, 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 2 Mar 2021.