Clinical Trials Logo
  1. Home
  2. Acute Myocardial Infarction
  3. NCT00704561

Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography — OCTAMI  

Acute Myocardial Infarction Clinical Trial

Official title:
Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).

Clinical Trial Summary

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.

Clinical Trial Description

Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00704561
Study type Interventional
Source A.O. Ospedale Papa Giovanni XXIII
Contact
Status Completed
Phase N/A
Start date April 2008
Completion date October 2009
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04451967 - Acute Myocardial Infarction Study in Northeastern China
Completed NCT05974397 - Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
Not yet recruiting NCT04072081 - Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03707626 - Collateral Circulation to LAD and Wellens Sign
Completed NCT02669810 - EXCELLENT (EXpanded CELL ENdocardiac Transplantation) Phase 2
Not yet recruiting NCT04104048 - Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
Active, not recruiting NCT02915107 - The SORT OUT IX STEMI OCT Trial N/A
Completed NCT02896543 - The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction N/A
Completed NCT02490969 - Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19 N/A
Completed NCT02531165 - Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention N/A
Withdrawn NCT01901471 - Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock Phase 2
Completed NCT02312336 - A Pilot Study of Transcoronary Myocardial Cooling N/A
Recruiting NCT02071342 - Study of ABSORB Stent in Acute Myocardial Infarction N/A
Completed NCT02070913 - COOL-AMI EU Case Series Clinical Study
Terminated NCT01972126 - MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction N/A
Completed NCT01887080 - Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program N/A
Withdrawn NCT01678339 - Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients N/A
Completed NCT01216995 - Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI) Phase 2
Completed NCT01627457 - Heart Cycle Prestudy N/A