Clinical Trials Logo

Clinical Trial Summary

The purpose of this multicenter, randomized, open label, parallel arm study whether the newest 3rd generation stent - Orsiro hybrid sirolimus-eluting stent is noninferior to the newest 2nd generation stent - Resolute Integrity zotarolimus-eluting stent in terms of 9 months in-stent late lumen loss. 345 Korean patients with a wide variety of coronary heart disease will be enrolled to this "all-comers" trial to give definite answer to the above hypothesis that is urgently needed.


Clinical Trial Description

The rate of restenosis after percutaneous coronary intervention (PCI) has dramatically decreased since the introduction of drug-eluting stents (DES). However, restenosis still remains a problem and some papers reported that the rate of restenosis can even go up to nearly 20% after the first-generation DES implantation, depending on the complexity of target lesion. Furthermore, there arises a concern about thrombogenic risk of these DES at the expense of reduced restenosis. Therefore, works aiming to reduce both restenosis and thrombosis are on-going, and there has been a rush of various second-generation DES with "biocompatible but non-absorbable polymer" and third-generation DES with "bioabsorbable polymer".

Recently, Orsiro hybrid sirolimus-eluting stent (Orsiro SES, Biotronik AG, Bulach, Switzeland) has been developed. It has a unique hybrid combination of polymers coated on thin cobalt-chromium struts (60um). The BIOlute® active component is a bioabsorbable polymer matrix combined with an anti-proliferative drug, sirolimus, and elutes the drug in a controlled manner after implantation, degrades over time and leaves only the PROBIO® coated stent behind in the long-term. The PROBIO® passive coating encapsulates the stent and protects interaction between the metal stent and the surrounding tissue. Although Orsiro SES showed excellent results in terms of late lumen loss at 9 months in first-in-man single arm trial (BIOFLOW-I trial), randomized controlled trials evaluating its efficacy and safety are limited to date.

The ORIENT Trial will evaluate the angiographic and clinical outcomes of the innovative third-generation DES, Orsiro SES, compared with the latest second-generation DES, Resolute Integrity zotarolimus-eluting stent (ZES-I, Medtronic Cardiovascular, Santa Rosa, California, USA), for treatment of patients with coronary artery disease. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01826552
Study type Interventional
Source Seoul National University Bundang Hospital
Contact
Status Completed
Phase Phase 4
Start date September 2013
Completion date June 2015

See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions N/A