The primary objective of the present study is the evaluation of the vascular healing process in patients previously treated with BVS implantation for ST-segment elevation myocardial infarction (STEMI). The healing process will be assessed evaluating…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be the evaluation of the healing process defined as
scaffold apposition and coverage at 6-month follow-up by invasive coronary
imaging with Optical Coherence Tomography.
Secondary outcome
The secondary OCT objective is the serial assessment of strut apposition from
baseline to 6-month follow-up in a subgroup of patients where an OCT study has
been performed at baseline, as clinically indicated.
Background summary
Everolimus eluting vascular scaffold (BVS) showed excellent safety and
performance for treatment of coronary artery disease, however the vascular
healing process following implantation of this device has been evaluated only
in stable patients.
Study objective
The primary objective of the present study is the evaluation of the vascular
healing process in patients previously treated with BVS implantation for
ST-segment elevation myocardial infarction (STEMI). The healing process will be
assessed evaluating BVS apposition and coverage at 6 months after implantation
using intravascular Optical Coherence Tomography.
Among 50 patients, a subgroup (n=30) will be exclusively comprised by patients
who had undergone OCT imaging at baseline, as indicated for clinical reasons.
Study design
A single centre, single arm investigator-driven pilot cohort study
Study burden and risks
The procedure of coronary angiography with the additional use of OCT can be
considered a standard procedure with a very low risk of major complications
(<2%). The mechanism of action and the safety of the OCT catheter are very well
known. OCT is a catheter-based technology producing ultra-high resolution,
cross-sectional, intravascular images from backscattered infrared
light-signals. A relevant amount of data has been produced on the use of the
OCT imaging modality in human coronary arteries. Very high feasibility and
safety of this technique were consistently reported. No effect on the local
tissue or on other organs-systems has been observed.
In addition patients with a previous acute coronary syndrome are at high risk
of cardiovascular events recurrence, therefore to perform a coronary angiogram
at 6-month after a myocardial infarction could be of additional benefit for
this patients as it could allow the early detection of a progression of the
coronary atherosclerotic disease.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Patient is at least 18 years of age.
2. Patient has been treated, within the previous 6 month, with BVS for primary PCI .
3. For the pre-specified subgroup of 30 patients, an OCT study of the treated culprit lesion after BVS implantation should be available for analysis.
4. Treated target lesion must be a de-novo lesion located in a native vessel.
5. Signed Informed Consent.
6. The patient understands and accepts the meaning and the aims of the study
Exclusion criteria
1. Pregnancy.
2. Known intolerance to contrast material.
3. Known thrombocytopenia (PLT< 100,000/mm3).
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 | NL44619.078.13 |