1) To investigate the differences in lipid content of the plaques after placement of a Stentys self-apposing stent. 2) To investigate whether there is a correlation between the decrease lpid-core content and the increase in cardiac biomarkers (…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Differences the maximum value of LCBI for any of the 4-mm segments in the
treated segment (max 4mm LCBI) pre- and post Stentys placement:
Secondary outcome
* Differences the maximum value of LCBI for any of the 4-mm segments in the
treated segment (max 4mm LCBI) pre- and post PCI.
* Differences in max 4mm LCBI pre- and post PCI in large lpid core plaques
(LCPs)
* Correlation between differences in max 4mm LCBI and peri-procedural MI:
Background summary
Previous studies have shown that there are large differences in lipid core
content pre- and post-PCI. This difference is associated with distal
embolization and periprocedural MIs. The presumed mechanism of MI after PCI of
large LCPs is distal embolization of lipid contents released during PCI.
Another mechanism has also been hypothesized; manipulation of lesions with
large LCPs liberates atheromatous material which can stimulate thrombus
formation which subsequently embolizes distally. The hypothesis of the current
observational study is that the use of a self-expanding stents such as the
Stentys stent is associated with less decrease of lipid-content of the plaque,
when compared with balloon expendable stent, due to less outward force.
Study objective
1) To investigate the differences in lipid content of the plaques after
placement of a Stentys self-apposing stent.
2) To investigate whether there is a correlation between the decrease lpid-core
content and the increase in cardiac biomarkers (occurence of peri-procedural
MIs) after PCI.
Study design
This is a prospective single center observational study, which evaluates the
differences of lipid content of a coronary atherosclerotic plaque after PCI
with a Stentys stent. Patients are eligible if they have a clinical diagnosis
of stable angina in whom a percutaneous coronary intervention is clinically
indicated. After coronary angiography, NIRS measurements of the culprit
lesion(s) are performed prior to PCI. After PCI and post-dilation, second and
third NIRS measurements are done of the stented lesions to evaluate the
decrease in lipid-core content.
Study burden and risks
Because a NIRS measurement is performed three times during the procedure, the
procedural time is prolonged with approximately 5 minutes (fluoroscopy time
with 1 minute). Although introducing an image catheter such as the NIRS
potentially increase the risk of dissections, we consider the additional risk
of NIRS imaging in the current protocol as being marginal, since the guidewires
are already introduced to treat the lesion. Furthermore, we would like to
emphasize the NIRS to be CE-marked and fully FDA-proved. The extra radiation
burden due to prolongment of the procedure will be calculated separately.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Patients with stable angina due to coronary artery stenosis.
2. Indication for PCI to treat this stenosis is set by the local heart team.
3. The lesion could be treated with a single Stentys stent
Exclusion criteria
1. Impaired renal function (eGFR <60 mls/min/1,73 m2)
2. Known allergies to aspirin, all thienopyridines (Plavix ®, Effient ®), heparin, stainless steel, copper or a sensitivity to contrast media which cannot be adequately pre-medicated
3. Disabling stroke within the past year
4. History of significant gastro-intestinal bleeding, bleeding diathesis or coagulopathy
5. Any prior bypass graft surgery
6. Prior or planned heart transplant or any other organ transplant
7. Planned major non-cardiac (for example oncological) surgery
8. Women who are pregnant or women of childbearing potential who do not use adequate contraception
9. Severe calcified lesions in which aggressive pre-dilatation with balloons is necessary.
10. Restenosis of a (previously treated) culprit lesion
11. Untreated left main disease with * 50% stenosis
12. Known tendency for coronary vasospasm
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 | NL42654.018.12 |