The influence of Stentys self-apposing stent on the lipid-core burden index assessed with near-infrared spectroscopy: could Stentys potentially prevent periprocedural MIs?

Completed

• Conditions: atherosclerosis of the coronary arteries; coronary artery disease; 10011082

• Registration Number: NL-OMON39928
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Differences the maximum value of LCBI for any of the 4-mm segments in the<br /><br>treated segment (max 4mm LCBI) pre- and post Stentys placement:</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Differences the maximum value of LCBI for any of the 4-mm segments in the<br /><br>treated segment (max 4mm LCBI) pre- and post PCI.<br /><br>* Differences in max 4mm LCBI pre- and post PCI in large lpid core plaques<br /><br>(LCPs)<br /><br>* Correlation between differences in max 4mm LCBI and peri-procedural MI:</p><br>