Coronary Artery Disease Clinical Trial
Official title:
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial
This study is a prospective, randomized controlled, single blind, two-arm, multicenter
clinical evaluation.
Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of
the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)
Polymer-Based Everolimus-Eluting Stent.
The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent
implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based
Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as
the primary imaging modality.
In patients with diabetes mellitus (DM), drug eluting stents (DES) have been shown to be
associated with greater neointimal suppression than bare-metal stents. However, there is an
ongoing debate on the optimal drug-eluting stent in diabetic patients.
This study is a prospective, randomized controlled, single blind, two-arm, multicenter
clinical evaluation.
Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of
the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)
Polymer-Based Everolimus-Eluting Stent.
The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent
implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based
Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as
the primary imaging modality.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| 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 | |
| Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
| Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
| 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 Korean Patients With Coronary De Novo Lesions
|
N/A |