Resolute ZES (zotarolimus-eluting stent) Trials

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Resolute ZES (zotarolimus-eluting stent) / Medtronic

SUGAR, NCT03321032: Second-generation Drug-eluting Stents in Diabetes

Active, not recruiting

1164

Europe

Polymer-free amphilimus-eluting stents, Biolinx Polymer-based zotarolimus-eluting stents

Spanish Society of Cardiology

Coronary Artery Disease, Diabetes Mellitus

01/21

01/22

NCT04137510: Bioflow-DAPT Study

Completed

1948

Europe, RoW

Percutaneous coronary intervention

Biotronik AG

Coronary Artery Disease

09/22

PECAD CTO, ChiCTR2400087491: The Efficacy and Safety of Drug-Coated Balloon Versus Drug-Eluting Stent in Treating Chronic Total Occlusion of Coronary Arteries: A Multi-center, Randomized, Controlled, Non-inferiority Clinical Trial

Not yet recruiting

166

Sequent Please Neo paclitaxel drug-coated balloon for dilation and drug release in CTO lesions.; Resolute Integrity Zotarolimus-eluting stent implanted in CTO lesions.

Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University, Shanghai hospital development center (SHDC12022111)

Coronary artery disease

ChiCTR-ONRC-14005020: ENDEAVOR SPRINT China Post Market Surveillance: Data Collection of the Endeavor Sprint Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China

Completed

N/A

2003

N/A

Medtronic (Shanghai) Management Co., Ltd.; Level of the institution：, Medtronic (Shanghai) Management Co., Ltd.

Symptomatic ischemic heart disease in de novo coronary artery lesions

NCT03118531: China Resolute Integrity 34/38 mm Study

Completed

N/A

RoW

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)

Medtronic Vascular

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease

07/18

04/23

NCT03376646: A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease

Completed

N/A

277

RoW

Cohort A: Dissolve™, Paclitaxel coated balloon, Cohort A: Resolute™ Integrity, Zotarolimus eluting stent, Cohort B: Dissolve™-2.00mm

DK Medical Technology (Suzhou) Co., Ltd., Core Medical (Beijing) Co., Ltd.

Coronary Small Vessel Disease

01/20

04/24

NCT03584464: RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Completed

N/A

205

Europe, US

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular

Coronary Artery Disease

11/20

09/22

FAME 3, NCT02100722: A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

Active, not recruiting

N/A

1500

Europe, Canada, US, RoW

FFR guided PCI, Fractional Flow Reserve-Guided PCI, CABG, Resolute Integrity Stent, Resolute Onyx Stent

Stanford University, VZW Cardiovascular Research Center Aalst, Catharina Ziekenhuis Eindhoven, Golden Jubilee National Hospital, University of California, Irvine, Medtronic, Abbott Medical Devices, Genae, King's College Hospital NHS Trust, Houston Methodist DeBakey Heart & Vascular Center

Coronary Disease, Coronary Stenosis

12/20

04/25

NCT03466151: RESOLUTE ONYX China RCT Study

Active, not recruiting

N/A

550

RoW

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease

02/21

09/25

NCT03471845: RESOLUTE ONYX China Single Arm Study

Active, not recruiting

N/A

591

RoW

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease

02/21

10/25

NCT04465669: Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation

Completed

N/A

RoW

Orsiro stents, Resolute Integrity® stents

Tomsk National Research Medical Center of the Russian Academy of Sciences

Coronary Heart Disease, Stable Angina Pectoris, Silent Myocardial Ischemia

12/21

12/22

BRONYX, NCT06577896: The Study to Evaluate the Safety and Efficacy of the Onyx Family

Recruiting

N/A

500

RoW

Onyx family, Onyx frontier, Resolute Onyx

Pusan National University Yangsan Hospital

Coronary Artery Disease

01/26

12/26

NCT04825886: Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease

Completed

N/A

2000

RoW

Zotarolimus-Eluting Stent

Chonnam National University Hospital

Coronary Artery Disease, Myocardial Ischemia, Coronary Disease

03/21

03/22

DCB-ACS, NCT04937803: Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes

Completed

N/A

216

RoW

Drug-coated balloon, Zotarolimus-Eluting Coronary Stent

Harbin Medical University, Daqing Oil Field Hospital, Sichuan Provincial People's Hospital, Tianjin People's Hospital, Peking University First Hospital, Beijing Friendship Hospital, The Third Medical Center, Chinese PLA General Hospital, Jining Medical University, Fuwai Central China Cardiovascular Hospital, The First Hospital of Jilin University, General Hospital of Taiyuan Iron & Steel Company, Tongji Hospital, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital of Zhengzhou University, Sir Run Run Shaw Hospital, Inner Mongolia People's Hospital

Drug-Coated Balloon, De Novo Stenosis, Acute Coronary Syndromes, ACS, DCB, Clinical Trial, Coronary Artery Disease

02/23

11/23

BIOADAPTOR, NCT04192747: The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries

Active, not recruiting

N/A

445

Europe, Japan, RoW

Percutaneous Coronary Intervention

Elixir Medical Corporation

Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis

02/23

02/27

ONYSOVER, NCT05340361: Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

Recruiting

N/A

RoW

Optical coherence tomography-guided percutaneous coronary intervention, Zotarolimus-eluting stent (Onyx family stent, Medtronic, Santa Rosa, CA, USA), Optical coherence tomography-guided Onyx family stent expansion

Yonsei University, Severance Hospital, Medtronic

Coronary Artery Disease, Optical Coherence Tomography, Stent

12/25

IRIS-Onyx, NCT02593994: Cohort in the IRIS-DES Registry

Recruiting

N/A

4500

RoW

Onyx Drug Eluting Stent group

Seung-Jung Park, CardioVascular Research Foundation, Korea, Medtronic Korea Co., Ltd.

Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases, Percutaneous Transluminal Angioplasty

12/25

12/29

CAGE-FREE III, NCT05209412: Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions

Active, not recruiting

N/A

370

RoW

Lepu Paclitaxel coated balloon, Resolute Integrity Zotarolimus eluting stents, Aspirin, Ticagrelor, Clopidogrel

Xijing Hospital

De Novo Stenosis, Coronary Artery Disease, Percutaneous Coronary Intervention

02/24

02/25

ZEVS-HBR, NCT05240781: Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk

Recruiting

N/A

280

RoW

Zotarolimus eluting stent, Resolute Onyx, Zotarolimus eluting stent (Medtronic, Santa Rosa, CA, USA), Sirolimus eluting stent, Ultimaster, Sirolimus eluting stent (Terumo; Tokyo, Japan), Ultimaster Tansei, Sirolimus eluting stent (Terumo; Tokyo, Japan)

Instituto Nacional de Cardiologia Ignacio Chavez

High Bleeding Risk, Coronary Artery Disease, Percutaneous Coronary Intervention

02/24

02/25

NCT04221815: IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact

Recruiting

N/A

3100

Europe, US, RoW

Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Resolute Onyx Drug Eluting Stent, Onyx Frontier Drug Eluting Stent, Onyx TruStar Drug Eluting Stent, Onyx TruCor Drug Eluting Stent

Medstar Health Research Institute

Atherosclerosis

04/27

08/27

BIOFLOW-DAPT, NCT05549440: BIOFLOW-Dual Anti-Platelet Therapy

Recruiting

N/A

RoW

Orsiro Mission, Resolute Onyx

Chinese University of Hong Kong

Percutaneous Intervention

06/24

09/24

TARGET-IV_NA, NCT04562532: Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

Active, not recruiting

N/A

1720

Europe, Canada, US

Microport Firehawk stent, MicroPort Firehawk rapamycin target eluting stent, 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)

Shanghai MicroPort Medical (Group) Co., Ltd.

Coronary Artery Disease

12/23

06/27

NCT04562805: Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)

Active, not recruiting

N/A

2400

Europe

DynamX Bioadaptor, Resolute Onyx

Elixir Medical Corporation, Uppsala University

Coronary Artery Disease, Ischemic Heart Disease

09/24

07/28

NCT05320926: Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial

Recruiting

N/A

3744

RoW

Clopidogrel monotherapy, Aspirin monotherapy, zotarolimus-eluting stent (Resolute Onyx ®)

Yonsei University

Ischemic Heart Disease

07/28

COMPASS, NCT05268094: Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The Trial)

Recruiting

N/A

300

Canada, US

Ductal Arterial Stent, Medtronic Resolute Onyx, Boston Scientific Promus Elite/Premier, Boston Scientific Synergy, Cordis Elunir, Abbott Xience, Systemic-to-Pulmonary Artery Shunt

Carelon Research, Pediatric Heart Network

Congenital Heart Disease in Children

09/26

04/27

MeRethonRCT, NCT05417893: Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions

Not yet recruiting

N/A

1872

MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS), XIENCE family Everolimus-eluting Coronary Stent System (EES), Resolute Zotarolimus-eluting Coronary Stent System (ZES), Synergy EES, BioMime/Metafor/Proficient family Sirolimus-eluting Coronary Stent System (SES)

Meril Life Sciences Pvt. Ltd.

Coronary Artery Disease

06/28

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Resolute ZES (zotarolimus-eluting stent) / Medtronic

SUGAR, NCT03321032: Second-generation Drug-eluting Stents in Diabetes

Active, not recruiting

1164

Europe

Polymer-free amphilimus-eluting stents, Biolinx Polymer-based zotarolimus-eluting stents

Spanish Society of Cardiology

Coronary Artery Disease, Diabetes Mellitus

01/21

01/22

NCT04137510: Bioflow-DAPT Study

Completed

1948

Europe, RoW

Percutaneous coronary intervention

Biotronik AG

Coronary Artery Disease

09/22

Not yet recruiting

166

Sequent Please Neo paclitaxel drug-coated balloon for dilation and drug release in CTO lesions.; Resolute Integrity Zotarolimus-eluting stent implanted in CTO lesions.

Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University, Shanghai hospital development center (SHDC12022111)

Coronary artery disease

ChiCTR-ONRC-14005020: ENDEAVOR SPRINT China Post Market Surveillance: Data Collection of the Endeavor Sprint Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China

Completed

N/A

2003

N/A

Medtronic (Shanghai) Management Co., Ltd.; Level of the institution：, Medtronic (Shanghai) Management Co., Ltd.

Symptomatic ischemic heart disease in de novo coronary artery lesions

NCT03118531: China Resolute Integrity 34/38 mm Study

Completed

N/A

RoW

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)

Medtronic Vascular

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease

07/18

04/23

NCT03376646: A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease

Completed

N/A

277

RoW

Cohort A: Dissolve™, Paclitaxel coated balloon, Cohort A: Resolute™ Integrity, Zotarolimus eluting stent, Cohort B: Dissolve™-2.00mm

DK Medical Technology (Suzhou) Co., Ltd., Core Medical (Beijing) Co., Ltd.

Coronary Small Vessel Disease

01/20

04/24

NCT03584464: RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Completed

N/A

205

Europe, US

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular

Coronary Artery Disease

11/20

09/22

FAME 3, NCT02100722: A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

Active, not recruiting

N/A

1500

Europe, Canada, US, RoW

FFR guided PCI, Fractional Flow Reserve-Guided PCI, CABG, Resolute Integrity Stent, Resolute Onyx Stent

Stanford University, VZW Cardiovascular Research Center Aalst, Catharina Ziekenhuis Eindhoven, Golden Jubilee National Hospital, University of California, Irvine, Medtronic, Abbott Medical Devices, Genae, King's College Hospital NHS Trust, Houston Methodist DeBakey Heart & Vascular Center

Coronary Disease, Coronary Stenosis

12/20

04/25

NCT03466151: RESOLUTE ONYX China RCT Study

Active, not recruiting

N/A

550

RoW

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease

02/21

09/25

NCT03471845: RESOLUTE ONYX China Single Arm Study

Active, not recruiting

N/A

591

RoW

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease

02/21

10/25

NCT04465669: Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation

Completed

N/A

RoW

Orsiro stents, Resolute Integrity® stents

Tomsk National Research Medical Center of the Russian Academy of Sciences

Coronary Heart Disease, Stable Angina Pectoris, Silent Myocardial Ischemia

12/21

12/22

BRONYX, NCT06577896: The Study to Evaluate the Safety and Efficacy of the Onyx Family

Recruiting

N/A

500

RoW

Onyx family, Onyx frontier, Resolute Onyx

Pusan National University Yangsan Hospital

Coronary Artery Disease

01/26

12/26

NCT04825886: Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease

Completed

N/A

2000

RoW

Zotarolimus-Eluting Stent

Chonnam National University Hospital

Coronary Artery Disease, Myocardial Ischemia, Coronary Disease

03/21

03/22

DCB-ACS, NCT04937803: Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes

Completed

N/A

216

RoW

Drug-coated balloon, Zotarolimus-Eluting Coronary Stent

Drug-Coated Balloon, De Novo Stenosis, Acute Coronary Syndromes, ACS, DCB, Clinical Trial, Coronary Artery Disease

02/23

11/23

BIOADAPTOR, NCT04192747: The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries

Active, not recruiting

N/A

445

Europe, Japan, RoW

Percutaneous Coronary Intervention

Elixir Medical Corporation

Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis

02/23

02/27

ONYSOVER, NCT05340361: Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

Recruiting

N/A

RoW

Yonsei University, Severance Hospital, Medtronic

Coronary Artery Disease, Optical Coherence Tomography, Stent

12/25

IRIS-Onyx, NCT02593994: Cohort in the IRIS-DES Registry

Recruiting

N/A

4500

RoW

Onyx Drug Eluting Stent group

Seung-Jung Park, CardioVascular Research Foundation, Korea, Medtronic Korea Co., Ltd.

Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases, Percutaneous Transluminal Angioplasty

12/25

12/29

CAGE-FREE III, NCT05209412: Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions

Active, not recruiting

N/A

370

RoW

Lepu Paclitaxel coated balloon, Resolute Integrity Zotarolimus eluting stents, Aspirin, Ticagrelor, Clopidogrel

Xijing Hospital

De Novo Stenosis, Coronary Artery Disease, Percutaneous Coronary Intervention

02/24

02/25

ZEVS-HBR, NCT05240781: Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk

Recruiting

N/A

280

RoW

Instituto Nacional de Cardiologia Ignacio Chavez

High Bleeding Risk, Coronary Artery Disease, Percutaneous Coronary Intervention

02/24

02/25

NCT04221815: IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact

Recruiting

N/A

3100

Europe, US, RoW

Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Resolute Onyx Drug Eluting Stent, Onyx Frontier Drug Eluting Stent, Onyx TruStar Drug Eluting Stent, Onyx TruCor Drug Eluting Stent

Medstar Health Research Institute

Atherosclerosis

04/27

08/27

BIOFLOW-DAPT, NCT05549440: BIOFLOW-Dual Anti-Platelet Therapy

Recruiting

N/A

RoW

Orsiro Mission, Resolute Onyx

Chinese University of Hong Kong

Percutaneous Intervention

06/24

09/24

TARGET-IV_NA, NCT04562532: Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

Active, not recruiting

N/A

1720

Europe, Canada, US

Microport Firehawk stent, MicroPort Firehawk rapamycin target eluting stent, 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)

Shanghai MicroPort Medical (Group) Co., Ltd.

Coronary Artery Disease

12/23

06/27

NCT04562805: Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)

Active, not recruiting

N/A

2400

Europe

DynamX Bioadaptor, Resolute Onyx

Elixir Medical Corporation, Uppsala University

Coronary Artery Disease, Ischemic Heart Disease

09/24

07/28

NCT05320926: Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial

Recruiting

N/A

3744

RoW

Clopidogrel monotherapy, Aspirin monotherapy, zotarolimus-eluting stent (Resolute Onyx ®)

Yonsei University

Ischemic Heart Disease

07/28

COMPASS, NCT05268094: Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The Trial)

Recruiting

N/A

300

Canada, US

Ductal Arterial Stent, Medtronic Resolute Onyx, Boston Scientific Promus Elite/Premier, Boston Scientific Synergy, Cordis Elunir, Abbott Xience, Systemic-to-Pulmonary Artery Shunt

Carelon Research, Pediatric Heart Network

Congenital Heart Disease in Children

09/26

04/27

Not yet recruiting

N/A

1872

Meril Life Sciences Pvt. Ltd.

Coronary Artery Disease

06/28



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