The objective for the study is to establish a proof of concept for the use of self-expandable stenting in subacute to chronic total occlusions and evaluate the safety and effectiveness of the STENTYS Coronary Stent System in the treatment of these…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be mean lumen area gain at 4-6 weeks follow-up,
measured by OCT. We hypothesize that this gain will be similar to the average
11.5% gain found in Apposition II, evaluated the STENTYS BMS with OCT after
implantation for a STEMI.
Secondary outcome
Secondary endpoints include assessment of both safety and effectiveness
endpoints, specifically:
1. Major Adverse Cardiac Events (MACE): defined as cardiac death, MI, emergent
bypass surgery (CABG), or clinically driven target lesion revascularization
(TLR) by percutaneous or surgical methods at discharge, 4-6 weeks, 6 and 12
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
discharge, 4-6 weeks, 6 and 12 months post-procedure.
3. Success Rates:
4. Device Success: Attainment of <30% final residual stenosis of the segment
of the culprit lesion covered by the STENTYS Stent, by visual estimation.
5. Procedure Success: Device success and no-peri-procedural complications.
6. Clinical Success: Procedural success and no in-hospital MACE.
7. Reperfusion post-procedural measured by TIMI flow.
8. Stent thrombosis at discharge, 4-6 weeks, 6 and 12 months post-procedure.
9. Imaging parameters (MLD, ISA, % stenosis) at the end of the procedure and
4-6 weeks
10. Presence of coronary spasm.
11. Presence of slow flow, no reflow phenomena
12. Mean and minimum lumen and stent area as measured by OCT at the end of the
procedure and after 4-6 weeks
13. Stent malapposition at the end of the procedure and 4-6 weeks.
Malapposition is defined as more than 5% mallaposed stent struts under OCT
Background summary
The treatment of subacute or chronic total coronary occlusion, defined as those
coronary occlusions which exist for more than three days or more than three
months, remain a topic for hot debate. The first issue is selecting those
patients who benefit from opening such an occlusion. Data from the OAT trial
shows that routine treatment of these occlusions does not improve rates of
clinical events in patients without severe inducible ischemia. Patients with a
CTO who, despite maximal medical therapy, remain symptomatic appear to benefit
from successful revascularization, improving symptoms and survival as well as
left ventricular function. A recently published study showed a difference in
5-year mortality of 17,2% after unsuccessful and 4.5% after successful CTO
recanalization.
Analysis of quantitative coronary angiography data has shown that, after
successful coronary revascularization of a CTO, distal vessel diameter
increases 12-18% over time. This increase is explained by endothelial and
smooth muscle cell dysfunction which is present directly after recanalization
and only partially recovers over time. This impaired vasomotion suggest
difficulties in choosing the correct stent size while it is known that
undersizing of a coronary stent leads to incomplete apposition and stent
thrombosis. Stent thrombosis is recognized as a potential fatal complication of
PCI, occurring after 1.7% of treated CTOs. It is our hypothesis that this
stent sizing dilemma can be alleviated by the use a self-expandable stent. The
first case-report of a CTO treated with a STENTYS stent showed promising
results with an 24% increase in mean lumen area after seven days when evaluated
with Optical Coherence Tomography (OCT), combined with excellent stent
apposition (A.J.J. Ijsselmuiden, EuroPCR 2013). This warrants the need for a
study examining the treatment of CTOs with the STENTYS self-expanding stent
evaluating stent apposition, stent growth in the treated segment and vessel
growth distal of the treated segment.
Study objective
The objective for the study is to establish a proof of concept for the use of
self-expandable stenting in subacute to chronic total occlusions and evaluate
the safety and effectiveness of the STENTYS Coronary Stent System in the
treatment of these subacute to chronic total occlusions in coronary arteries.
Study design
This is a prospective, mono-centre, observational study consisting of one arm
of 20 patients. Patients will be treated with the self expanding STENTYS
DES(P).
Intervention
Patients meeting all selection criteria will receive a STENTYS DES stent
Study burden and risks
The physical examination procedure takes place and some questions about the
history of the patients are asked. Then
the (index) procedure will be performed during which an angiography will be
made (=standard).
During the 4-6 week follow-up an angiogram will be made and OCT imaging is
performed. At this time questions regarding medication, and adverse events en
overall physical wellbeing will be asked.
Six months after the procedure questions will be asked regarding medication,
and adverse events en overall physical wellbeing. This will be
repeated 1 year after the procedure.
albert schweitzerplaats 25
Dordrecht 3318 AT
NL
albert schweitzerplaats 25
Dordrecht 3318 AT
NL
Listed location countries
Age
Inclusion criteria
1. Patient with a total or subtotal occlusion as evidenced by angiography and under optimal drug regimen amenable for revascularization.
2. Subject >=18 years.
3. Reference vessel diameter >=2.5mm and <=6mm preferably measured by QCA, or if QCA not possible by visual estimate.
4. Subject understands the nature of the procedure and provides written informed consent prior to the procedure.
5. Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone
Exclusion criteria
1. Acute coronary syndromes, but not post-infarction AP
2. Cardiogenic shock.
3. Any vasculature lesions or characteristics preventing PCI, introduction of the STENTYS delivery system or placement of the STENTYS Stent.
4. Allergies or contraindications to antiplatelet medication, contrast or to stent components which cannot be adequately treated.
5. Female patient with child bearing potential not taking adequate contraceptives.
6. Participation in another investigational drug or device study in which the primary endpoint has not been reached yet and that interferes with this study.
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 | NL47306.101.13 |