11 completed, 5 active not recruiting, 2 terminated, 1 withdrawn. 8 Not applicable, 3 Phase 2, 3 Phase 4, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 8 | Completed 6, Active not recruiting 2 |
| Phase 2 | 3 | Completed 3 |
| Phase 4 | 3 | Completed 1, Terminated 1, Withdrawn 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Support C Post-Market Registry Coronary Arteriosclerosis | Active not recruiting | OrbusNeich | 282 | 2025-07-09 | 2026-02-10 | |
| VITUS Post-Market Registry Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon - Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease | Active not recruiting | OrbusNeich | 283 | 2025-05-22 | 2026-08-13 | |
| EucaLimus Post-Market Registry EucaLimus coronary stent system - Coronary Arterioscleroses | Active not recruiting | OrbusNeich | 251 | 2025-03-14 | 2026-03-11 | |
| Sapphire 3 CTO Study Sapphire 3 Coronary Dilatation Catheter - Coronary Artery Disease, Coronary Disease | Not applicable | Completed | OrbusNeich | 170 | 2024-11-06 | 2026-01-12 |
| Scoreflex TRIO - Scoring PTCA Catheter OrbusNeich Scoreflex TRIO, OrbusNeich Scoreflex NC - Coronary Arteriosclerosis | Not applicable | Completed | OrbusNeich | 210 | 2023-04-27 | 2024-08-26 |
| Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent PCI with BioMatrix Alpha™ stent, PCI with Combo™ stent - Coronary Artery Disease | Not applicable | Active not recruiting | Phillip Freeman | 3141 | 2019-08-14 | 2023-04-26 |
| Scoreflex NC - Scoring PTCA Catheter Scoreflex NC Scoring PTCA catheter - Coronary Artery Disease, Coronary Disease | Not applicable | Completed | OrbusNeich | 200 | 2019-02-27 | 2021-08-11 |
| SORT OUT X - Combo Stent Versus ORSIRO Stent COMBO, ORSIRO - Coronary Heart Disease, Angina Pectoris | Not applicable | Active not recruiting | Aarhus University Hospital Skejby | 3148 | 2017-06-01 | 2023-11-28 |
| Sapphire II PRO US Clinical Study Sapphire II PRO - Coronary Artery Disease, Coronary Disease | Not applicable | Completed | OrbusNeich | 61 | 2017-05-05 | 2018-05-11 |
| COMBO-Stent in Patients on Chronic Anticoagulant Therapy (COSTA) COSTA-Bleed and COSTA-Outcome Trials COMBO-Stent, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran, Any drug eluting stent oder bare metal sent - Stable Angina, Unstable Angina | Phase 4 | Withdrawn | IHF GmbH - Institut für Herzinfarktforschung | 2016-04-01 | 2017-02-20 | |
| Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions OrbusNeich Combo stent™, sirolimus-eluting stent system - Coronary Arteriosclerosis | Not applicable | Completed | OrbusNeich | 440 | 2015-05-01 | 2021-09-09 |
| MASCOT - Post Marketing Registry OrbusNeich COMBO stent - Coronary Artery Disease, Atherosclerosis | Completed | OrbusNeich | 2500 | 2014-06-01 | 2017-08-01 | |
| HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt OrbusNeich Combo stent™, Everolimus Eluting Stent (EES) - Coronary Arteriosclerosis, Non ST Segment Elevation Acute Coronary Syndrome | Not applicable | Completed | OrbusNeich | 572 | 2014-02-01 | 2022-05-13 |
| Deutsches Dual Therapy Stent Register Coronary Artery Disease | Terminated | OrbusNeich | 130 | 2013-07-01 | 2017-11-20 | |
| Study of Vascular Healing With the Combo Stent Versus the Everolimus Eluting Stent in ACS Patients by Means of OCT PTCA with stent placement - Coronary Artery Disease, Atherosclerosis | Phase 2 | Completed | OrbusNeich | 60 | 2011-10-01 | 2014-03-24 |
| Safety and Efficacy Study of Endothelial Progenitor Cell Capture Stent With 1 Months Dual Antiplatelet Therapy Endothelial cell capture stent with 1 month clopidogrel, Everolimus eluting stent with 12 month clopidogrel, Atorvastatin 20mg loading - Stable Angina | Phase 4 | Terminated | Yonsei University | 1 | 2011-10-01 | 2013-12-04 |
| Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting Stent coronary stenting - Coronary Artery Lesions | Phase 2 | Completed | OrbusNeich | 180 | 2009-11-01 | 2016-03-29 |
| Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries Genous stent implantation with paclitaxel-eluting balloon dilation, Genous stent implantation - Coronary Artery Disease | Phase 2 / Phase 3 | Completed | University of Ulm | 120 | 2009-02-01 | 2014-06-10 |
| Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth Coronary stent implantation - Coronary Artery Disease, Coronary Artery Stenosis | Phase 4 | Completed | OrbusNeich | 100 | 2006-08-01 | 2014-04-08 |
Coronary Artery Disease (14) · Coronary Disease (8) · Cardiovascular Diseases (6) · Heart Diseases (6) · Myocardial Ischemia (6) · Arteriosclerosis (5) · Angina, Stable (2) · Atherosclerosis (2) · Myocardial Infarction (2) · Acute Coronary Syndrome (1) · Angina Pectoris (1) · Angina, Unstable (1) · Coronary Stenosis (1) · Non-ST Elevated Myocardial Infarction (1) · Peripheral Arterial Disease (1)
Angioplasty (1) · Atorvastatin (1) · Clopidogrel (1) · Dabigatran (1) · Phenprocoumon (1) · Rivaroxaban (1)
Germany (6) · Spain (4) · United States (4) · Belgium (3) · Netherlands (3) · China (2) · Czechia (2) · Denmark (2) · Malaysia (2) · United Kingdom (2) · Australia (1) · Austria (1) · Finland (1) · France (1) · Japan (1)
David Kandzari, MD (3) · Alexandra Lansky, MD (1) · Alexandre Abizaid, MD (1) · Antonio Colombo, MD (1) · Bernward Lauer, MD, PhD (1) · Fernando Alfonso, MD, PhD (1) · Ian T Meredith, MBBS, PhD (1) · Ibrahim Akin (1) · Josep Gomez-Lara, MD, PhD (1) · Jun Bo Ge, MD (1) · Koen Deloose, MD (1) · Lars Jakobsen, MD (1) · Michael Haude, MD, PhD (1)
PMID 21763653, PMID 23523459, PMID 25983165, PMID 26479969, PMID 28279316, PMID 29807307, PMID 29931092, PMID 30826192, PMID 32111358, PMID 32198837, PMID 32418717, PMID 33781677, PMID 33823606, PMID 37584207, PMID 39870125, PMID 40406942