Healing Response to Everolimus-eluting Stent Implantation; Serial

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate serial changes of neointimal coverage after everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.

Clinical Trial Description

Late and very late stent thrombosis is current main issue after introduction of drug-eluting stents .Possible causes of these stent thromboses include thrombus formation resulting from delayed neointimal coverage, spasms occurring at the distal end of the stent implantation site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel or rapamycin, and vascular endothelial damage induced by the polymer. For BMS, neointimal coverage begins within the first one month after stent implantation and almost completes in three months. For DES, sirolimus eluting stents (SES) for example, neointimal coverage is markedly delayed after stent implantation and the exposed stent struts may be largely attributable to the occurrence of late stent thrombosis.

On the other hand, everolimus eluting stents (EES), which have a thinner stent strut layer and improved polymer biocompatibility, it has been reported that earlier and more normal neointimal coverage can be achieved compared with other first-generation DESs, SES and paclitaxel eluting stents (PES). These findings suggest that coverage with vascular endothelium differs among different DES platforms. Optical coherence tomography (OCT) has a resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular ultrasound (IVUS). It is therefore necessary to use OCT to accurately evaluate cross-sectional images of the stent struts covered with vascular endothelium. However, no studies have reported the results of continuous observation and evaluation of EES covered with endothelium.

Therefore, the investigators investigate time course of neointimal coverage of EES through detailed evaluation by OCT of neointimal coverage at 3, 6, and 12 months after stent implantation. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01689688
Study type	Observational
Source	Kobe University
Contact
Status	Recruiting
Phase	N/A
Start date	September 2012
Completion date	October 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Completed	`NCT05088291` - Application of a New X-ray Protective Device in Coronary Interventional Therapy
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Completed	`NCT04584645` - A Digital Flu Intervention for People With Cardiovascular Conditions	N/A
Not yet recruiting	`NCT04995159` - Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System	N/A
Recruiting	`NCT02967718` - Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome	N/A
Completed	`NCT02888652` - Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Terminated	`NCT02045134` - Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery	N/A
Completed	`NCT02163044` - The Hellenic Postprandial Lipemia Study (HPLS)
Active, not recruiting	`NCT02244853` - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease	N/A
Completed	`NCT01920009` - Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines	N/A
Completed	`NCT01826552` - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent	Phase 4
Completed	`NCT02440893` - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Terminated	`NCT01906957` - Cognition and Exercise Training	N/A
Completed	`NCT02753829` - Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease	N/A
Completed	`NCT01779401` - Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients	N/A
Recruiting	`NCT01462799` - COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care	N/A
Recruiting	`NCT01456364` - Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing	Phase 4
Completed	`NCT01486030` - Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test
Completed	`NCT01428947` - Does Coronary Angiography Cause Cognitive Dysfunction?	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography — HEAL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms