Coronary Artery Disease Clinical Trial
Official title:
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.
rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery
disease has led to a significant reduction in morbidity. However, the first generation of
these devices had no positive impact on the mortality after PCI (compared to bare metal
stents), which was greatly attributed to a somewhat increased incidence of late and very
late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of
inflammation and finally adverse events also led to the development of DES with
bioresorbable coatings, which leave after degradation of the coating only a bare metal stent
in the vessel wall that does not induce an inflammatory response. While such bioresorbable
polymer DES are increasingly used in clinical practice, data from head-to-head comparisons
between bioresorbable polymer DES with a contemporary highly flexible new generation
permanent polymer coated DES.
Aim:
The aim of the study is to compare the outcome of the bioresorbable polymer coated stent
(ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an
all-comers patient population and non-inferiority setting.
Study design:
The study is a prospective, randomized, single-blinded, multicentre trial with 1:1
randomization for drug-eluting stent type, stratified for gender and the presence of
diabetes mellitus.
Study population:
Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary
stenoses with an indication for DES use, according to current guidelines and/or the
operators clinical judgement. All clinical syndromes will be included. A total of 2,470
patients will be included.
Intervention:
One group will receive the ORSIRO stent, the other group will receive the RESOLUTE ONYX
stent. All other intervention and procedural characteristics are similar.
Primary study outcome:
Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC definitions).
Components of the primary endpoint in hierarchical order: - Cardiac death: all deaths are
considered cardiac, unless an unequivocal non-cardiac cause can be established. - Target
vessel related myocardial infarction (MI) that is Q-wave or non-Q-wave, that can be related
to the target vessel or cannot be related to another vessel. - Clinically driven repeated
target vessel revascularization by means of PCI or coronary artery bypass grafting (CABG).
;
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 |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
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 |
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 | |
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |