The primary objective of the present study is the evaluation of the vascular healing process in patients with diabetes mellitus treated with BVS implantation for NSTEMI, stable or unstable angina, or silent ischemia. The healing process will be…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the evaluation of the scaffold coverage at 6-month
follow-up by invasive coronary imaging with Optical Coherence Tomography.
Secondary outcome
Secondary objectives of the present investigation include OCT, QCA, NIRS
imaging (baseline and 6 month) and clinical endpoints (until 5 years follow-up)
Background summary
The everolimus eluting bioresorbable vascular scaffold (BVS) demonstrated
excellent safety and performance for treatment of coronary artery disease,
however, the vascular healing response following implantation of this device in
high-risk patients, in particular patients with diabetes mellitus, has not been
evaluated
Study objective
The primary objective of the present study is the evaluation of the vascular
healing process in patients with diabetes mellitus treated with BVS
implantation for NSTEMI, stable or unstable angina, or silent ischemia. The
healing process will be assessed evaluating BVS coverage 6 months
post-implantation by intravascular Optical Coherence Tomography.
Study design
A single centre, single arm investigator-initiated observational pilot cohort
study
Study burden and risks
The procedure of coronary angiography with the additional use of OCT and NIRS
imaging can be considered a standard procedure with a very low risk of major
complications (0.4%). The mechanism of action and the safety of the OCT and
NIRS imaging catheters are very well known. The OCT and NIRS imaging systems
are both catheter-based technologies 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 and NIRS imaging modalities in human coronary arteries. Very high
feasibility and safety of these techniques are consistently reported. No effect
on the local tissue or on other organs-systems has been observed.
In addition, patients with a previous coronary syndrome are at high risk of
recurrence of cardiovascular events, therefore to perform a coronary angiogram
with additional intracoronary imaging pre, post and 6 months post-scaffold
implantation could be of additional benefit as it could allow the evaluation of
the early (pre- and post-procedure) and longer-term (6 months) effects of
scaffold implantation and it could allow the early detection of a progression
of the coronary atherosclerotic disease (6 months imaging).
'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 is know with diabetes mellitus
3. Patient presenting with NSTEMI, stable or unstable angina , or silent ischemia caused by a de novo stenotic lesion in a native previous untreated coronary artery
4. Dmax (proximal and distal mean lumen diameter) within the upper limit of 3.8 mm and the lower limit of 2.0 mm by online QCA (at the moment only for the 2.5 mm and 3.5 mm devices)
5. The patient understands and accepts the meaning and the aims of the study
6. The patient is willing to comply with specified follow-up evaluation and can be contacted by telephone (Signed Informed Consent)
Exclusion criteria
1. Previous CABG
2. Cardiogenic shock
3. STEMI patients requiring immediate stent implantation
4. Bifurcation lesion requiring kissing balloon postdilatation
5. Allergies or contraindications to antiplatelet medication or contrast material
6. Female patient with child bearing potential not taking adequate contraceptives or currently breasfeeding
7. Expected survival of < 1 year
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 | NL45678.078.13 |