This study aims to determine the percentage of changes in decision making regarding sizing and optimization of apposition of the magnesium scaffold as a result of OCT imaging before and after implantation of the scaffold compared to an angiographic…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objectives:
- Percentage of cases in which changes are made in selecting stent size and
length after the initial OCT run compared to an angiographic based strategy.
- Percentage of cases in which changes are made in post-stenting strategy after
the final OCT run compared to an angiographic based strategy.
Secondary outcome
Secondary objectives:
- Fractional flow reserve (FFR) measured before and after placement of the
Magnesium biodegradable stent, to determine to what extend FFR is influenced by
the presence of the stent in the vessel segment.
- the occurence of cardiac events after 6 and 12 months follow up.
Background summary
Since the first use of drug eluting stents in coronary arteries, the risk of
restenosis and stent thrombosis has been dramatically decreased. However, the
permanent presence of metal struts in the arterial wall is believed to be
disadvantageous regarding thrombus formation, as well as impairment of
endothelial response and vasomotive aspects that are lost once the intima is
covered in metal struts. A bioresorbable drug eluting stent would overcome
these advantages e.g. the magmaris stent.
However, another reason for thrombus formation is the malapposition of a stent
due to undersizing or inadequate deployment which often not obvious from the
angiogram and becomes apparent with the use of optical coherence tomography
(OCT). This malapposition will have an effect of the hemodynamic profile of the
stent especially in these biodegradable stents which have larger strut
thickness compared to the metal stents.
This study aims to determine the percentage of changes in decision making
regarding sizing and optimization of apposition of the Magmaris magnesium
scaffold as a result of OCT imaging before and after implantation of the
scaffold in comparison to angiographic sizing. FFR measurement adds functional
information to these anatomical parameters.
Study objective
This study aims to determine the percentage of changes in decision making
regarding sizing and optimization of apposition of the magnesium scaffold as a
result of OCT imaging before and after implantation of the scaffold compared to
an angiographic based strategy. FFR measurement adds functional information to
these anatomical parameters.
Study design
Prospective observational design.
Study burden and risks
There is no additional risk for the patient when participating in this study.
All treatment modalities are standard equipment in the cathlab. FFR is used in
most PCI cases in the cathlab, it has a Class 1A recommendation for lesion
analysis pre-PCI in the European Society of Cardiology guidelines for
revascularization8. Use of OCT is strongly recommended when placing a
biodegradable stent and thus can be considered standard of care. Potential
benefit derives from the use of state of the state of the art biodegradable
stent combined with the use of FFR and OCT. Risks related to FFR or OCT are low
and almost always temporary.
Michelangolaan 2
Eindhoven 5623 EJ
NL
Michelangolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
In this study, patients from 18 years are eligible for inclusion if they are scheduled for PCI. De-novo lesions in a 3,0-3,5 mm artery up to 25mm are suitable to be treated.
All patients have to be able to give written informed consent.
Exclusion criteria
- patients < 18 years
- Cardiogenic shock
- severe calcification or chronic occluded artery.
- bifurcation lesions
- previous bypass surgery
- pregnancy
- inability to give informed consent
- contra-indication for adenosine infusion such as allergy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60386.100.17 |