The primary objective is to assess the safety and operation of the Stentys coronary stent system in patients with acute myocardial infarction compared with a balloon-expanding stent. These are the effect and safety in the short term (the procedure…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Stent strut malapposition at 3 days (±2 days) measured by OCT. Malapposition is
defined as the distance between the leading edge of the strut and the leading
edge of the contour bigger than the strut thickness.
Side branches (with floating struts) will not be considered for analysis of the
primary endpoint.
Secondary outcome
1. Major Adverse Cardiac Events (MACE): defined as cardiac death, re-MI,
emergent bypass surgery (CABG), or clinically driven target lesion
revascularization (TLR) by percutaneous or surgical methods at 30 days, and 6
months post-procedure
2. Target vessel failure (TVF), defined as cardiac death, target vessel
myocardial infarction (MI) [Q or Non Q-Wave], or clinically driven target
vessel revascularization (TVR) by percutaneous or surgical methods at 30 days
and 6 months.
3. Acute Success Rates:
a) Device Success: Attainment of <30% final residual stenosis of the target
lesion by visual estimation using only the assigned stent prior to OCT.
b) Procedure Success: Attainment of < 30% final residual stenosis of the target
lesion by visual estimation and no in-hospital MACE.
4. Stent thrombosis at 30 days and 6 months
5. Abrupt closure of Side Branch >2.0 mm (TIMI<3)
6. Angiographic Endpoints (by QCA)
Background summary
Percutaneous intervention with stent placement is first choice of treatment of
acute myocardial infarction. The most used stent, is the balloon-expandable
stent. In this context it is important to note that there seems to be a
relationship with trauma to the vessel wall caused by high balloon pressures
before and after stent placement and restenosis in the long term. The
self-expandable stent Stentys shows a much more gradual expansion and allows
much lower pressure balloon, the result is less damage to the vessel wall and
probably the better long term results with decreased restenosis. Another
advantage of the Stentys stent that should be investigated is the possibility
to treat side branches (bifurcations), because the stent has the special
property that the connections may be disconnected by a balloon and thereby
provide access to the branch, both during the procedure and long term. The
stent is compared with a balloon-expandable stent. The randomization ratio of
the study is 1 / 1. Stentys stent has been tested in 65 patients in a
bifurcationstudy, but this concerns elective patients - 30 days results
presented at the TCT (6 months follow-up is in progress). Also, there are 20
patients enrolled in Apposition I (not randomized study in AMI patients) with
no device related adverse reaction (follow-up in progress). This study should
answer the question whether the Stentys stent safe and effective in patients
with an acute myocardial infarction and stent apposition how the Stentys stent
is compared to a balloon-expandable stent
Study objective
The primary objective is to assess the safety and operation of the Stentys
coronary stent system in patients with acute myocardial infarction compared
with a balloon-expanding stent. These are the effect and safety in the short
term (the procedure can be successfully implemented? Can The stent placed
tightly against the wall, what are the reactions to ontlag from the hospital?)
and long (2 years for the group stentys) term? Its major tributaries good
deal?)
Study design
International, randomized, prospective, multi-center, two-arm clinical study.
Approximately 80 subjects will be enrolled in approximately 10 centers.
Intervention
Patients meeting all selection criteria are randomized to receive or STENTYS
stent or control stent (Abbott ML VISION stent or Medtronic Driver stent) in a
1 / 1 ratio.
Study burden and risks
The physical examination will take place and some questions about patients
history will be made. The OCT is repeated within a few days after PCI . During
the procedure after 3 days a physical examination will be performed again. An
angiogram and OCT will be performed again and there are also questions about
the medication and possible side effects.
All these investigations are normal clinical standard of these patients,
except the angiogram and the OCT three days after the baseline PCI is no part
of standard care.
25 Rue Choiseul
75002 Parijs
NL
25 Rue Choiseul
75002 Parijs
NL
Listed location countries
Age
Inclusion criteria
Subjects presenting with acute myocardial infarction with a de novo stenotic lesion in a native coronary artery amenable to revascularization with percutaneous coronary intervention with stent deployment.;Inclusion criteria
1.Subject >=18 years old.
2. Myocardial infarction
3. candidate for CABG
4. Patient understands nature of research and is willing to comply to follow-up investigations
5. vessel diameter is between 2.5 and 4.0 mm and length is < 30mm
Exclusion criteria
1. Currently enrolled in another investigational study
2. Coronary or cardiac intervention or major surgery of any kind within 30 days prior to the procedure.
3. Patients on anticoagulation therapy (Coumadin)
4. Cardiogenic shock
5. Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.
6. Cerebrovascular accident or transient ischemic attack in the last 6 months.
7. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
8. Known serum creatinine level >2.5mg/dl or presence or history of renal failure
9. Target lesion is severely calcified.
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 | NL29854.078.09 |