The primary objective of this study is to assess the neointimal healing score (as evaluated by intra-coronary OFDI) in patients with STEMI and treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) at 6 months…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Presence of filling defect (%ILD) is assigned weight of *4*,
2. Presence of both malapposed and uncovered struts (%MN) is assigned a weight
of *3*,
3. Presence of uncovered struts alone (%N) is assigned a weight of *2* and
finally,
4. Presence of malapposition alone (%M) is assigned a weight of *1*.
Secondary outcome
Clinical Endpoints (in-hospital/post-procedure, at 1 and 6 months and yearly up
to 3 years follow-up)
* Procedure success (no in-hospital DoCE).
* Device-oriented Composite Endpoints at 1 month and 6 months and annually to 3
years and its individual components. (Device-oriented Composite Endpoint (DoCE)
is defined as cardiac death, MI not clearly attributable to a non-intervention
vessel, and clinically-indicated target lesion revascularization)
* All-cause death at all timepoints
* Any MI at all timepoints
* Non ischemia-driven target lesion revascularization TLR at al timepoints
* Ischemia-driven and non ischemia-driven target vessel revascularization (TVR)
at all timepoints
* Scaffold/Stent thrombosis according to ARC definition at all timepoints.
* Angina class at all timepoints
* Other SAEs at all timepoints.
Imaging Endpoints
* Angiographic endpoints (pre- and post-procedure and at 6 months)
o Percent diameter stenosis (%DS) at; in-segment, in-device, proximal and distal
o Minimal lumen diameter (MLD) at; in-segment, in-device, proximal and distal
o Lumen Loss (LL); in-segment, in-device, proximal and distal
o Angiographic binary restenosis (ABR) at; in-segment, in-device, proximal and
distal
* OFDI Endpoints (6 months)
o All individual components of the Healing Score at 6 months;
o Mean/minimal scaffold/stent diameter/area/volume at 6 months;
o Mean/minimal lumen diameter/area/volume at 6 months;
o Incomplete strut apposition (ISA) area/volume at 6 months;
o Percentage of covered struts at 6 months;
o Mean/maximal thickness of the struts coverage at 6 months;
o Neointimal hyperplasia area/volume at 6 months;
o Mean Flow area/volume at 6 months;
o Intraluminal defect area/ volume at 6 months;
o Thickness of neointimal tissue developed over lipid rich plaque at 6 months
(*research project*).
Background summary
We hypothesize that acutely and at intermediate follow-up (i.e. 6 months)
implantation of the ABSORB fully bioresorbable everolimus-eluting scaffold is
at least as safe as implantation of metallic drug-eluting stent, and that at
late follow-up the ABSORB scaffold could improve the arterial healing process
and potentially reduce late stent thrombosis in patients presenting with STEMI.
Since the previous ABSORB trials as well as ongoing trials only include stable
patients with simple lesions, the polymeric device has not been prospectively
investigated in patients presenting with STEMI. The purpose of this study is
therefore to test the feasibility of the everolimus-eluting bioresorbable
scaffold implantation in STEMI and to assess the healing process documented on
OFDI 6 months after implantation.
Study objective
The primary objective of this study is to assess the neointimal healing score
(as evaluated by intra-coronary OFDI) in patients with STEMI and treated with
Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS)
at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE).
Study design
This is a prospective, randomized, active control, single-blind,
non-inferiority, European multi-center clinical trial. Approximately 190
subjects will be registered at up to 8-10 European sites. Subjects will be
followed for 3 years.
All eligible patients (STEMI <24 hours from onset of chest pain) will be
randomized to
* Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold
system (BVS) or
* XIENCE Everolimus Eluting Coronary Stent System (XIENCE Xpedition)
All patients will undergo optical frequency domain imaging (OFDI) investigation
of the culprit lesion at 6 months follow-up.
Intervention
All eligible patients (STEMI <24 hours from onset of chest pain) will be
randomized to
* Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold
system (BVS) or
* XIENCE Everolimus Eluting Coronary Stent System (XIENCE Xpedition)
All patients will undergo optical frequency domain imaging (OFDI) investigation
of the culprit lesion at 6 months follow-up.
Study burden and risks
There is extensive clinical and commercial experience worldwide with cardiac
catheterization and interventional procedures and it is expected that the
procedural risks in this study and existing stenting procedure will not be
significantly different.
Potential benefits of study device:
1. Decrease of late ischemic adverse events
Complete biodegradation of stent struts prevents the risk of thrombus
formation at sites of impaired endothelialization and may reduce the risk of
very late stent thrombosis
2. Restoration of vascular biology during follow-up. Normalization of
vasomotion and compensatory remodeling were observed following implantation of
BVS suggesting restoration of normal vessel physiology after complete
biodegradation of the stent struts. Culprit lesions of STEMI patients are
frequently localized in the proximal segments of the coronary artery tree.
Restoration of physiological vasomotion may therefore have a greater impact in
patients with STEMI as compared to patients with stable coronary artery disease.
3. No interference with diagnostic or therapeutic measures in case of disease
progression As the scaffold disappears, non-invasive diagnostic imaging is not
hampered by the presence of metallic stents. In case of a progression of a
coronary artery disease, no foreign body material will limit the selection of
the distal anastomosis of coronary artery bypass grafts.
4. Improved vascular healing after stent implantation into vulnerable plaques
The vulnerable plaque composition in STEMI lesions interferes with vascular
healing after metallic stent implantation 13, and may lead to coronary
evagination formation or late acquired malapposition, features which have been
correlated with adverse ischemic outcomes. Complete biodegradation of the
scaffold may reduce long-term stent related adverse events.
5. Discontinuation of longterm antiplatelet therapy in patients with
single-vessel coronary artery disease Patients with STEMI often present with
single-vessel coronary artery disease and would eventually not necessitate
long-term antiplatelet therapy. Following the implantation of a metallic DES,
lifelong antiplatelet therapy is recommended because of the presence of a
foreign body. With the assurance of a completely resorbable scaffold,
discontinuation of antiplatelet therapy after 1-2 years may result in decreased
rates of bleeding events.
Westblaak 92
Rotterdam 3012 KM
NL
Westblaak 92
Rotterdam 3012 KM
NL
Listed location countries
Age
Inclusion criteria
1. Subject must be at least 18 years of age;
2. Primary PCI within 24 hours of symptom onset;
3. ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguous anterior leads;
4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery within planned device deployment segment (Dmax) by visual estimation of * 2.5 mm and * 3.8 mm;
5. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 6 months following the index procedure.
Exclusion criteria
1. Inability to provide informed consent;
2. Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization;
3. Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material;
4. Cardiogenic Shock;
5. Unprotected left main coronary artery stenosis;
6. Distal occlusion of target vessel;
7. Acute myocardial infarction secondary to stent thrombosis;
8. Mechanical complications of acute myocardial infarction;
9. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter;
10. Fibrinolysis prior to PCI;
11. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy;
12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
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 |
|---|---|
| ClinicalTrials.gov | NCT01986803 |
| CCMO | NL46160.099.13 |