Clinical trials: de Novo Coronary Lesions
Atherosclerosis, Coronary Artery Disease
The OMEGA Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.
- Trial name
- NCT01419171
- Testing
- OMEGA™ Monorail Coronary Stent System
- Where
- 37 sites in United States, Belgium and 5 more
- Volunteers
- 328 people
- Sponsor
- Boston Scientific Corporation
Coronary Disease, Coronary Artery Disease
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- NCT01171820
- Testing
- TAXUS® Liberté™, XIENCE V® EECSS
- Where
- 28 sites in Austria, France and 9 more
- Volunteers
- 324 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
Absorb IV Randomized Controlled Trial
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02173379
- Testing
- Absorb BVS, XIENCE
- Where
- 120 sites in United States, Australia and 3 more
- Volunteers
- 2,604 people
- Sponsor
- Abbott Medical Devices
Arterial Occlusive Diseases, Myocardial Ischemia
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
- Conditions
- Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- RJ (NCT00927940)
- Testing
- MDT-4107 Drug Eluting Stent
- Where
- 14 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Vascular
Coronary Arteriosclerosis
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
- Trial name
- NCT00968019
- Testing
- Presillion stent
- Where
- 13 sites in Portugal, Spain
- Volunteers
- 318 people
- Sponsor
- Johnson and Johnson, S.A.
Coronary Artery Disease
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects.
- Trial name
- ORBIT II (NCT01092416)
- Testing
- Diamondback 360 Orbital Atherectomy System
- Where
- 51 sites in United States
- Volunteers
- 443 people
- Sponsor
- Abbott Medical Devices
Myocardial Ischemia, Coronary Artery Stenosis
ABSORB EXTEND Clinical Investigation
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- ABSORB EXTEND (NCT01023789)
- Testing
- ABSORB BVS
- Where
- 56 sites in Argentina, Australia and 23 more
- Volunteers
- 812 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Resolute Integrity US Extended Length Sub-Study(RI US XL)
Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel…
- Trial name
- RI-US XL (NCT01913600)
- Testing
- Resolute Integrity Stent
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.
- Trial name
- PLATINUM (NCT00823212)
- Testing
- PROMUS Coronary Stent System, PROMUS Element Coronary Stent System, Aspirin
- Where
- 133 sites in United States, Australia and 15 more
- Volunteers
- 1,530 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Myocardial Ischemia
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart…
- Trial name
- ABSORB JAPAN (NCT01844284)
- Testing
- XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS
- Where
- 39 sites in Japan
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
- Trial name
- NCT04058990
- Testing
- Device: Paclitaxel-Coated PTCA Balloon Catheter, SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
- Where
- 14 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Coronary Artery Stenosis
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB CHINA (NCT01923740)
- Testing
- XIENCE V EECSS, Absorb BVS System
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
ABSORB III Randomized Controlled Trial (RCT)
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB-III (NCT01751906)
- Testing
- Absorb BVS, XIENCE
- Where
- 192 sites in United States, Australia
- Volunteers
- 2,008 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®).
- Trial name
- NCT00307047
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 3,687 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-V (NCT02389946)
- Testing
- Orsiro DES, Xience DES
- Where
- 92 sites in United States, Australia and 11 more
- Volunteers
- 1,334 people
- Sponsor
- Biotronik, Inc.
Coronary Artery Disease
TAXUS PERSEUS Small Vessel
The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo…
- Trial name
- PERSEUS SV (NCT00489541)
- Testing
- Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
- Where
- 28 sites in United States
- Volunteers
- 224 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Coronary Atherosclerosis
Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems
The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for…
- Trial name
- ELITE (NCT00715884)
- Testing
- CYPHER® ELITE™ Sirolimus-Eluting Stent System, CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
- Where
- United States
- Volunteers
- 678 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.
- Trial name
- PLATINUM PK (NCT01510327)
- Testing
- PROMUS Element Everolimus-Eluting Coronary Stent System, Aspirin, Thienopyridine
- Where
- 5 sites in United States, Japan
- Volunteers
- 22 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries.
The objective of this study is to verify the safety and efficacy of the Endeavor Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of…
- Trial name
- ENDEAVORSVS (NCT00609947)
- Testing
- Endeavor Zotarolimus-Eluting Coronary Stent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Medtronic Vascular
Coronary Disease, Coronary Artery Disease
ABSORB Clinical Investigation, Cohort B
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB B (NCT00856856)
- Testing
- Bioabsorbable Everolimus Eluting Coronary Stent
- Where
- 12 sites in Australia, Belgium and 6 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices