RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Sponsor
Medtronic Vascular (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03584464
Collaborator
(none)
205
Enrollment
25
Locations
1
Arm
55.6
Anticipated Duration (Months)
8.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
205 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Actual Study Start Date :
May 14, 2018
Actual Primary Completion Date :
Nov 4, 2020
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Other: Bifurcation Cohort

Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Target Vessel Failure (TVF) [12 Months]

    Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

Secondary Outcome Measures

  1. Number of Participants With Cardiac Death [12 months]

    Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.

  2. Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) [Up to 12 months]

    Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)

  3. Number of Participants With Target Lesion Revascularization (TLR) [12 months]

    Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.

  4. Number of Participants With Target Vessel Revascularization (TVR) [12 months]

    Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.

  5. Number of Participants With Cardiac Death and TVMI [12 months]

    Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.

  6. Number of Participants With Major Adverse Cardiac Event (MACE) [12 months]

    Major Adverse Cardiac Event (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods.

  7. Number of Participants With Target Lesion Failure (TLF) [12 months]

    Target Lesion Failure (TLF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods.

  8. Number of Participants With Stent Thrombosis (ARC) Definite/Probable [12 months]

    Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC). Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable: Any unexplained death within the first 30 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Key Inclusion Criteria

  • Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction

  • Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki

  • Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique

Exclusion Criteria:
  • Unprotected left main disease

  • Subjects with planned PCI of three vessel disease

  • Planned two stent technique (main branch and side branch) of a bifurcation

  • Subjects with more than one bifurcation lesion

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Huntsville HospitalHuntsvilleAlabamaUnited States35801-4421
2Scripps Green HospitalLa JollaCaliforniaUnited States92037
3Riverside Community HospitalRiversideCaliforniaUnited States92506-0102
4Hartford HospitalHartfordConnecticutUnited States06106-5527
5Morton Plant HospitalClearwaterFloridaUnited States33756
6North Florida Regional Medical CenterGainesvilleFloridaUnited States32605-4524
7Tallahassee Memorial HospitalTallahasseeFloridaUnited States32308-4646
8WellStar Kennestone HospitalMariettaGeorgiaUnited States30060-1125
9University of Michigan Health SystemAnn ArborMichiganUnited States48109-5869
10Mercy HospitalCoon RapidsMinnesotaUnited States55433-4568
11Abbott NorthwesternMinneapolisMinnesotaUnited States55407-1195
12Nebraska Medical CenterOmahaNebraskaUnited States68198-2265
13Desert Springs HospitalLas VegasNevadaUnited States89118-3011
14St. Josephs Hospital Health CenterEast SyracuseNew YorkUnited States13057-9208
15North Shore University HospitalManhassetNew YorkUnited States11030
16NYU Langone Medical CenterNew YorkNew YorkUnited States10016
17New York-Presbyterian Hospital/ Columbia University Medical CenterNew YorkNew YorkUnited States10032-3729
18Baptist Memorial Hospital-MemphisGermantownTennesseeUnited States38138-1727
19Houston Methodist HospitalHoustonTexasUnited States77030
20University of Virginia Medical CenterCharlottesvilleVirginiaUnited States22903
21Saint Vincent HospitalGreen BayWisconsinUnited States54301
22CHU CharleroiCharleroiBelgium6042
23Ziekenhuis Oost LimburgGenkBelgium3600
24CHU Toulouse - Hôpital RangueilToulouseFrance50032 31059
25Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.sBanska BystricaSlovakia97401

Sponsors and Collaborators

  • Medtronic Vascular

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT03584464
Other Study ID Numbers:
  • V 4.0 16Feb2018
First Posted:
Jul 12, 2018
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Period Title: Overall Study
STARTED205
COMPLETED204
NOT COMPLETED1

Baseline Characteristics

Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm in diameter for the treatment of a bifurcation lesion with provisional stenting.
Overall Participants205
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
87
42.4%
>=65 years
118
57.6%
Sex: Female, Male (Count of Participants)
Female
44
21.5%
Male
161
78.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
12
5.9%
Not Hispanic or Latino
182
88.8%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
8
3.9%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
11
5.4%
White
159
77.6%
More than one race
15
7.3%
Unknown or Not Reported
0
0%
Region of Enrollment (Count of Participants)
United States
167
81.5%
Europe
38
18.5%

Outcome Measures

1. Primary Outcome
TitleNumber of Participants With Target Vessel Failure (TVF)
DescriptionTarget Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Time Frame12 Months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
14
6.8%
2. Secondary Outcome
TitleNumber of Participants With Cardiac Death
DescriptionCardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
3
1.5%
3. Secondary Outcome
TitleNumber of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)
DescriptionTarget Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
Time FrameUp to 12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
6
2.9%
4. Secondary Outcome
TitleNumber of Participants With Target Lesion Revascularization (TLR)
DescriptionTarget Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
7
3.4%
5. Secondary Outcome
TitleNumber of Participants With Target Vessel Revascularization (TVR)
DescriptionTarget Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
8
3.9%
6. Secondary Outcome
TitleNumber of Participants With Cardiac Death and TVMI
DescriptionCardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
9
4.4%
7. Secondary Outcome
TitleNumber of Participants With Major Adverse Cardiac Event (MACE)
DescriptionMajor Adverse Cardiac Event (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
17
8.3%
8. Secondary Outcome
TitleNumber of Participants With Target Lesion Failure (TLF)
DescriptionTarget Lesion Failure (TLF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
13
6.3%
9. Secondary Outcome
TitleNumber of Participants With Stent Thrombosis (ARC) Definite/Probable
DescriptionStent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC). Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable: Any unexplained death within the first 30 days.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants204
Count of Participants [Participants]
0
0%

Adverse Events

Time Frame12 months
Adverse Event Reporting Description
Arm/Group TitleBifurcation Cohort
Arm/Group DescriptionSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
All Cause Mortality
Bifurcation Cohort
Affected / at Risk (%)# Events
Total6/205 (2.9%)
Serious Adverse Events
Bifurcation Cohort
Affected / at Risk (%)# Events
Total48/205 (23.4%)
Blood and lymphatic system disorders
Normocytic Anaemia1/205 (0.5%) 1
Cardiac disorders
Acute Left Ventricular Failure1/205 (0.5%) 1
Acute Myocardial Infarction4/205 (2%) 4
Angina Pectoris4/205 (2%) 4
Angina Unstable1/205 (0.5%) 1
Atrial Fibrillation2/205 (1%) 2
Atrioventricular Block Second Degree1/205 (0.5%) 1
Bradycardia1/205 (0.5%) 1
Cardiac Arrest2/205 (1%) 2
Cardiac Failure Congestive2/205 (1%) 3
Coronary Artery Disease4/205 (2%) 4
Coronary Artery Dissection1/205 (0.5%) 1
Sinus Arrest1/205 (0.5%) 1
Gastrointestinal disorders
Diverticulum Intestinal1/205 (0.5%) 1
Intestinal Obstruction1/205 (0.5%) 2
Melaena1/205 (0.5%) 2
Rectal Haemorrhage1/205 (0.5%) 1
General disorders
Chest Pain1/205 (0.5%) 1
Death1/205 (0.5%) 1
Non-Cardiac Chest Pain1/205 (0.5%) 1
Vascular Stent Stenosis1/205 (0.5%) 1
Vessel Puncture Site Haematoma1/205 (0.5%) 1
Immune system disorders
Drug Hypersensitivity1/205 (0.5%) 1
Infections and infestations
Cellulitis1/205 (0.5%) 1
Covid-191/205 (0.5%) 1
Gastroenteritis Viral1/205 (0.5%) 1
Influenza1/205 (0.5%) 1
Localised Infection1/205 (0.5%) 1
Pneumonia3/205 (1.5%) 3
Sepsis2/205 (1%) 2
Septic Shock1/205 (0.5%) 1
Injury, poisoning and procedural complications
Cardiac Procedure Complication1/205 (0.5%) 1
Postoperative Respiratory Failure1/205 (0.5%) 1
Procedural Pain1/205 (0.5%) 1
Investigations
Myocardial Necrosis Marker Increased3/205 (1.5%) 3
Musculoskeletal and connective tissue disorders
Back Pain1/205 (0.5%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer1/205 (0.5%) 1
Rectal Adenocarcinoma1/205 (0.5%) 1
Nervous system disorders
Carotid Artery Stenosis1/205 (0.5%) 1
Cerebrovascular Accident2/205 (1%) 2
Dizziness1/205 (0.5%) 1
Paraesthesia1/205 (0.5%) 1
Unresponsive To Stimuli1/205 (0.5%) 1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure1/205 (0.5%) 1
Chronic Obstructive Pulmonary Disease1/205 (0.5%) 3
Dyspnoea1/205 (0.5%) 1
Respiratory Failure2/205 (1%) 2
Surgical and medical procedures
Carotid Endarterectomy1/205 (0.5%) 1
Coronary Artery Bypass1/205 (0.5%) 1
Vascular disorders
Haematoma1/205 (0.5%) 1
Hypotension1/205 (0.5%) 1
Peripheral Arterial Occlusive Disease1/205 (0.5%) 1
Other (Not Including Serious) Adverse Events
Bifurcation Cohort
Affected / at Risk (%)# Events
Total39/205 (19%)
Blood and lymphatic system disorders
Anaemia2/205 (1%) 2
Blood Loss Anaemia1/205 (0.5%) 1
Cardiac disorders
Angina Pectoris1/205 (0.5%) 1
Bradycardia1/205 (0.5%) 1
Bundle Branch Block Left1/205 (0.5%) 1
Coronary Artery Disease3/205 (1.5%) 3
Coronary Artery Dissection2/205 (1%) 2
Coronary Artery Occlusion1/205 (0.5%) 1
Left Ventricular Dysfunction1/205 (0.5%) 1
Ventricular Tachycardia1/205 (0.5%) 1
Gastrointestinal disorders
Gingival Bleeding1/205 (0.5%) 1
Pneumoperitoneum1/205 (0.5%) 1
General disorders
Chest Discomfort1/205 (0.5%) 1
Chest Pain2/205 (1%) 2
Injection Site Haemorrhage1/205 (0.5%) 1
Malaise1/205 (0.5%) 1
Vascular Stent Stenosis2/205 (1%) 2
Infections and infestations
Urinary Tract Infection1/205 (0.5%) 1
Injury, poisoning and procedural complications
Cardiac Procedure Complication1/205 (0.5%) 1
Face Injury1/205 (0.5%) 1
Patella Fracture1/205 (0.5%) 1
Periprocedural Myocardial Infarction1/205 (0.5%) 1
Plaque Shift1/205 (0.5%) 1
Vascular Access Complication1/205 (0.5%) 1
Vascular Access Site Swelling1/205 (0.5%) 1
Investigations
Inflammatory Marker Increased1/205 (0.5%) 1
Myocardial Necrosis Marker Increased7/205 (3.4%) 7
Troponin I Increased1/205 (0.5%) 1
Troponin Increased3/205 (1.5%) 3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma1/205 (0.5%) 1
Intraductal Proliferative Breast Lesion1/205 (0.5%) 1
Nervous system disorders
Headache1/205 (0.5%) 1
Paraesthesia1/205 (0.5%) 1
Seizure1/205 (0.5%) 1
Renal and urinary disorders
Nephrolithiasis1/205 (0.5%) 1
Urinary Retention1/205 (0.5%) 1
Respiratory, thoracic and mediastinal disorders
Dyspnoea1/205 (0.5%) 1
Vascular disorders
Labile Hypertension1/205 (0.5%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/TitleAlissa Anderson, Clinical Study Manager
OrganizationMedtronic, plc
Phone7075912434
Emailalissa.anderson@medtronic.com
Responsible Party:
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT03584464
Other Study ID Numbers:
  • V 4.0 16Feb2018
First Posted:
Jul 12, 2018
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022