Trials / Unknown
UnknownNCT02770651
Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI
LAte Stent Strut APPosition and COverage After Drug-Eluting Stent ImplantaTIOn by Optical Coherence Tomography in PatieNts With Acute Myocardial Infarction II(APPOSITION-AMI II)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 69 (estimated)
- Sponsor
- Keimyung University Dongsan Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.
Detailed description
It has been known that persistence of polymer may affect the late/very late safety and efficacy of drug eluting stent (DES) although polymer provides a reservoir for programmed drug release. Newer durable polymers may have enhanced biocompatibility and seem to be associated with improved clinical outcomes. However, they have still been incriminated in the occurrence of inflammation, neo-atherosclerosis, and thrombosis. Therefore, the investigators will evaluate the vascular tissue reaction after different kinds of DES implantation under the high thrombogenic circumstance of acute myocardial infarction (AMI).
Conditions
- Coronary Artery Disease
- Coronary Disease
- Myocardial Ischemia
- Arterial Occlusive Diseases
- Arteriosclerosis
- Cardiovascular Diseases
- Heart Diseases
- Vascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Everolimus-Eluting stent | Everolimus-Eluting stent with bioabsorbable polymer |
| DEVICE | Zotarolimus-Eluting stent | Zotarolimus-Eluting stent with permanent polymer |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-06-01
- Completion
- 2018-12-01
- First posted
- 2016-05-12
- Last updated
- 2018-01-25
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02770651. Inclusion in this directory is not an endorsement.