To assess if treatment of an intermediate vulnerable coronary lesion in symptomatic patients using a BVS is feasible, results in a more stable plaque, increases vessel luminal area, preserves or improves vasomotion and is not associated with…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite endpoint of change in plaque cumulative score of signs of
vulnerability on CT and nominal change in percent necrotic core and thin-cap
fibroatheroma at VH-IVUS at 24 months
Secondary outcome
A. assessment of vessel and lesion:
- change in target lesion cumulative score of signs of vulnerability based on
CT at 24 months
- change in target plaque volume based on CT at 24 months
- change in necrotic core volume based on CT at 24 months
- change in positive remodelling index on CT at 24 months
- change in total plaque volume on CT at 24 months
- remaining target lesion stenosis based on CT at 24 months
- Nominal change in in percent necrotic core and thin-cap fibroatheroma at
VH-IVUS at 24 months
- Remaining plaque thickness based on VH-IVUS at 24 months
- Change in vessel area, lumen area, plaque area (vessel area - minus lumen
area), and plaque burden [(plaque area/vessel area) × 100] at 24 months
- change in plaque composition on VH-IVUS at 24 months
- change in mean lumen diameter (MLD) pre *and post nitroglycerine infusion
based on quantative coronary analysis (QCA) at 24 months.
- change in mean lumen diameter (MLD) pre *and post acetylcholine infusion
based on quantative coronary analysis (QCA) at 24 months.
B. Safety
- Successful delivery and deployment of the BVS in the intended target lesion
with residual stenosis of less than 50%
- Occurrence of death, (periprocedural) MI <30 days and at one year.
- Need for Target Vessel Revascularization (TVR) at 12 months
- Need for Target Lesion Revascularization (TLR) at 12 months
- Occurrence of definite/probable scaffold thrombosis <30days and at 12 months
according to academic research consortium (ARC) definition.
- Target vessel failure (TVF) at 12 months after BVS implantation
- Target lesion failure (TLF) at 12 months after BVS
Background summary
Acute coronary syndromes (ACS) are associated with the more early, vulnerable
plaques resulting in plaque rupture and local thrombus formation. Symptomatic
patients with intermediate stenosis (*50% stenosis on coronary CT) with signs
of vulnerability, have a 7-fold increased risk for all-cause mortality,
non-fatal MI and late revascularization. Implantation of a bioresorbable
vascular scaffold (BVS) for intermediate coronary lesions with morphological
signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS)
could stabilize the plaque, improve natural vasomotion and increase vascular
diameter and potentially reduce risk for ACS, where after the scaffold fully
resolves.
Study objective
To assess if treatment of an intermediate vulnerable coronary lesion in
symptomatic patients using a BVS is feasible, results in a more stable plaque,
increases vessel luminal area, preserves or improves vasomotion and is not
associated with procedure or scaffold related complications.
Study design
Single centre, feasibility study.
Intervention
Implantation of bioresorbable vascular scaffold.
Study burden and risks
First coronary CT and angiogram including FFR, are part of routine clinical
work-up. Patients will have to undergo a second coronary CT and angiogram at 24
months after inclusion. Radiation and contrast burden for the second CT and
angiogram will be very limited and only focus on the target vessel. Repeat CT
and angiogram have been performed many times in numerous studies and as a
side-effect offer the opportunity to re-evaluate coronary anatomy. For VH-IVUS
measurements a small catheter is advanced in the vessel using a guide wire. In
rare cases (limited) injury of the vessel wall might occur. The administration
of acetylcholine and nitroglycerine is considered a safe way to evaluate
endothelial function. Implantation of BVS is considered safe with low MACE
rate. Potential complications are local dissection, restenosis and stent
thrombosis. BVS related MACE is estimated 3.4 to 7% without any deaths, whereas
MACE for conservative treated vulnerable, intermediate lesions is estimated 3.9
to 11.3%, including death.
Weg door Jonkerbos 100
Nijmegen 6532 SZ
NL
Weg door Jonkerbos 100
Nijmegen 6532 SZ
NL
Listed location countries
Age
Inclusion criteria
- Symptomatic patients between the age of 18 and 80 years
- Morise Risk score of *9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
- Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
- FFR negative lesion at coronary angiogram
- Vessel diameter *2.5 mm on visual estimate
Exclusion criteria
- High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
- Lesions located in a coronary vessels previously stented.
- Left main (>50%) or known three vessel disease.
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.
Design
Recruitment
Medical products/devices used
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 | NL46063.091.13 |