A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Sponsor
Medtronic Vascular (Industry)
Overall Status
Completed
CT.gov ID
NCT03647475
Collaborator
(none)
752
4
1
30.7
188
6.1
Study Details
Study Description
Brief Summary
The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
752 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, multi-center, single arm trial enrolling eligible subjects in the United States and Japan. Subjects will remain in the study with follow-up clinical assessments through 2 years, study exit, or death, whichever comes first.Prospective, multi-center, single arm trial enrolling eligible subjects in the United States and Japan. Subjects will remain in the study with follow-up clinical assessments through 2 years, study exit, or death, whichever comes first.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Onyx ONE Clear: A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Actual Study Start Date
:
Oct 1, 2018
Actual Primary Completion Date
:
Mar 10, 2020
Actual Study Completion Date
:
Apr 22, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. |
Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
|
Outcome Measures
Primary Outcome Measures
- Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction [One Month to one year]
Composite of cardiac death and myocardial infarction at one year for a one-month clear population [Time Frame: One month to one year]
Secondary Outcome Measures
- Number of Participants With Target Lesion Failure [One Month to One Year]
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 method
- Number of Participants With Procedure Success [Procedure to hospital discharge, an average of 1.3 days]
Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
- All Participants Deaths Including Cardiac Death [One Month to One Year]
All participants deaths including cardiac death
- Number of Patients With Major Cardiac Event [One Month to One Year]
Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
- Number of Patients With Myocardial Infarction [One Month to One Year]
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
- Number of Patients With Target Vessel Failure [One Month to One Year]
Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.
- Number of Patients With Revascularization [One Month to One Year]
All revascularizations (TLR, TVR and non-TVR)
- Number of Patients With Stent Thrombosis [One Month to One Year]
Stent thrombosis (per Academic Research Consortium (ARC) definition)
- Number of Patients With Bleeding [One Month to One Year]
Bleeding per BARC (Bleeding Academic Research Consortium) criteria. This criteria classifies bleeding events with BARC 1 being the least severe and type 5 being the most severe. Grouping of BARC categories: BARC 3 to 5 - This included all bleeding events in BARC 3 to BARC 5 categories BARC 2 to 5- This included all bleeding events in BARC 2 to BARC 5 categories All BARC- This included all bleeding events BARC 1 through BARC 5
- Number of Patients With Stroke [One Month to One Year]
Stroke
- Lesion Success [End of Procedure, an average of 42 minutes]
The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
- Device Success [End of Procedure an average of 42 minutes]
Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below:
-
Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
-
Age ≥ 75 years old
-
Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
-
Any prior documented intracerebral bleed
-
Any documented stroke in the last 12 months
-
Hospital admission for bleeding during the prior 12 months
-
Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
-
Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI
-
Planned surgery that would require interruption of DAPT (within the next 12 months)
-
Renal failure defined as: Creatinine clearance <40 ml/min
-
Thrombocytopenia (PLT <100,000/mm3)
-
Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
-
Expected non-compliance for at least 6 months DAPT for other medical reasons
Exclusion Criteria:
-
Pregnant and breastfeeding women
-
Subjects requiring a planned PCI procedure after 1 month of index procedure
-
Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
-
Active bleeding at the time of inclusion
-
Cardiogenic shock
-
Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
-
Subject not expected to comply with long-term single antiplatelet therapy
-
A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
-
PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
-
Participation in another clinical study within 12 months after index procedure
-
Subjects with life expectancy of less than 2 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saint Joseph's Hospital Health Center | East Syracuse | New York | United States | 13057 |
| 2 | New York- Presbyterian Hospital/Columbia University Medical Center | New York | New York | United States | 10032 |
| 3 | AnMed Health Medical Center | Anderson | South Carolina | United States | 29621 |
| 4 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Medtronic Vascular
Investigators
- Principal Investigator: David Kandzari, MD, Piedmont Atlanta Hospital, Atlanta, GA
- Principal Investigator: Ajay Kirtane, MD, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT03647475
Other Study ID Numbers:
- MDT18015RES008
First Posted:
Aug 27, 2018
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 | Per protocol, the 752 subjects enrolled in the US & Japan were pooled with A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients" (NCT03344653). Subjects enrolled under NCT03344653 were in regions outside of the US and Japan. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Period Title: Overall Study | |
| STARTED | 752 |
| NCT03647475 - Included in One Month Clear Analysis Population | 601 |
| NCT03344653- Included in One Month Clear Analysis Population | 905 |
| COMPLETED | 75 |
| NOT COMPLETED | 677 |
Baseline Characteristics
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Overall Participants | 1506 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
241
16%
|
| >=65 years |
1265
84%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
74
(9.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
487
32.3%
|
| Male |
1019
67.7%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (Count of Participants) | |
| United States |
564
37.5%
|
| Japan |
37
2.5%
|
| Australia |
85
5.6%
|
| Austria |
11
0.7%
|
| Belgium |
27
1.8%
|
| Bulgaria |
52
3.5%
|
| France |
12
0.8%
|
| Hong Kong |
20
1.3%
|
| Ireland |
27
1.8%
|
| Italy |
61
4.1%
|
| Latvia |
11
0.7%
|
| Lithuania |
6
0.4%
|
| Malaysia |
100
6.6%
|
| Netherlands |
50
3.3%
|
| New Zealand |
33
2.2%
|
| Norway |
2
0.1%
|
| Poland |
23
1.5%
|
| Singapore |
8
0.5%
|
| Slovakia |
92
6.1%
|
| Spain |
98
6.5%
|
| Sweden |
25
1.7%
|
| Switzerland |
12
0.8%
|
| Thailand |
1
0.1%
|
| United Kingdom |
43
2.9%
|
| South Korea |
106
7%
|
Outcome Measures
| Title | Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction |
|---|---|
| Description | Composite of cardiac death and myocardial infarction at one year for a one-month clear population [Time Frame: One month to one year] |
| Time Frame | One Month to one year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
104
6.9%
|
| Title | Number of Participants With Target Lesion Failure |
|---|---|
| Description | 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 method |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
121
8%
|
| Title | Number of Participants With Procedure Success |
|---|---|
| Description | Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. |
| Time Frame | Procedure to hospital discharge, an average of 1.3 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
1295
86%
|
| Title | All Participants Deaths Including Cardiac Death |
|---|---|
| Description | All participants deaths including cardiac death |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
89
5.9%
|
| Title | Number of Patients With Major Cardiac Event |
|---|---|
| Description | Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
174
11.6%
|
| Title | Number of Patients With Myocardial Infarction |
|---|---|
| Description | All myocardial infarction including Target Vessel Myocardial Infarction (TVMI) |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
72
4.8%
|
| Title | Number of Patients With Target Vessel Failure |
|---|---|
| Description | Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods. |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
131
8.7%
|
| Title | Number of Patients With Revascularization |
|---|---|
| Description | All revascularizations (TLR, TVR and non-TVR) |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
84
5.6%
|
| Title | Number of Patients With Stent Thrombosis |
|---|---|
| Description | Stent thrombosis (per Academic Research Consortium (ARC) definition) |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
10
0.7%
|
| Title | Number of Patients With Bleeding |
|---|---|
| Description | Bleeding per BARC (Bleeding Academic Research Consortium) criteria. This criteria classifies bleeding events with BARC 1 being the least severe and type 5 being the most severe. Grouping of BARC categories: BARC 3 to 5 - This included all bleeding events in BARC 3 to BARC 5 categories BARC 2 to 5- This included all bleeding events in BARC 2 to BARC 5 categories All BARC- This included all bleeding events BARC 1 through BARC 5 |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| All BARC |
195
12.9%
|
| BARC 3 to 5 |
60
4%
|
| BARC 2 to 5 |
175
11.6%
|
| Title | Number of Patients With Stroke |
|---|---|
| Description | Stroke |
| Time Frame | One Month to One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Count of Participants [Participants] |
22
1.5%
|
| Title | Lesion Success |
|---|---|
| Description | The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method |
| Time Frame | End of Procedure, an average of 42 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Measure Lesions | 1960 |
| Number [Lesions] |
1817
|
| Title | Device Success |
|---|---|
| Description | Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only. |
| Time Frame | End of Procedure an average of 42 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear. |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent |
|---|---|
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
| Measure Participants | 1506 |
| Measure Lesions | 1960 |
| Number [Lesions] |
1790
|
Adverse Events
| Time Frame | From One Month to 365 Days | |
|---|---|---|
| Adverse Event Reporting Description | For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis. | |
| Arm/Group Title | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent | |
| Arm/Group Description | Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. | |
All Cause Mortality |
||
| Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent | ||
| Affected / at Risk (%) | # Events | |
| Total | 89/1506 (5.9%) | |
Serious Adverse Events |
||
| Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent | ||
| Affected / at Risk (%) | # Events | |
| Total | 591/1506 (39.2%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 34/1506 (2.3%) | 38 |
| Anaemia Macrocytic | 1/1506 (0.1%) | 1 |
| Blood Loss Anaemia | 6/1506 (0.4%) | 6 |
| Coagulopathy | 1/1506 (0.1%) | 1 |
| Disseminated Intravascular Coagulation | 1/1506 (0.1%) | 1 |
| Febrile Neutropenia | 1/1506 (0.1%) | 1 |
| Iron Deficiency Anaemia | 7/1506 (0.5%) | 7 |
| Lymphadenopathy | 1/1506 (0.1%) | 1 |
| Microcytic Anaemia | 1/1506 (0.1%) | 1 |
| Nephrogenic Anaemia | 2/1506 (0.1%) | 2 |
| Normocytic Anaemia | 2/1506 (0.1%) | 2 |
| Thrombocytopenia | 4/1506 (0.3%) | 4 |
| Cardiac disorders | ||
| Acute Coronary Syndrome | 8/1506 (0.5%) | 9 |
| Acute Left Ventricular Failure | 5/1506 (0.3%) | 5 |
| Acute Myocardial Infarction | 38/1506 (2.5%) | 40 |
| Angina Pectoris | 26/1506 (1.7%) | 26 |
| Angina Unstable | 16/1506 (1.1%) | 16 |
| Anginal Equivalent | 1/1506 (0.1%) | 1 |
| Aortic Valve Stenosis | 3/1506 (0.2%) | 3 |
| Arrhythmia | 1/1506 (0.1%) | 1 |
| Atrial Fibrillation | 48/1506 (3.2%) | 59 |
| Atrial Flutter | 8/1506 (0.5%) | 8 |
| Atrial Tachycardia | 1/1506 (0.1%) | 1 |
| Atrioventricular Block | 2/1506 (0.1%) | 2 |
| Atrioventricular Block Complete | 5/1506 (0.3%) | 5 |
| Atrioventricular Block First Degree | 1/1506 (0.1%) | 1 |
| Atrioventricular Block Second Degree | 2/1506 (0.1%) | 2 |
| Bradycardia | 8/1506 (0.5%) | 8 |
| Bundle Branch Block Left | 1/1506 (0.1%) | 1 |
| Bundle Branch Block Right | 1/1506 (0.1%) | 1 |
| Cardiac Arrest | 6/1506 (0.4%) | 6 |
| Cardiac Asthma | 1/1506 (0.1%) | 1 |
| Cardiac Failure | 21/1506 (1.4%) | 22 |
| Cardiac Failure Acute | 8/1506 (0.5%) | 9 |
| Cardiac Failure Chronic | 2/1506 (0.1%) | 2 |
| Cardiac Failure Congestive | 40/1506 (2.7%) | 52 |
| Cardiogenic Shock | 1/1506 (0.1%) | 1 |
| Cardiomyopathy | 2/1506 (0.1%) | 2 |
| Chronic Left Ventricular Failure | 1/1506 (0.1%) | 1 |
| Conduction Disorder | 1/1506 (0.1%) | 1 |
| Coronary Artery Disease | 14/1506 (0.9%) | 15 |
| Coronary Artery Dissection | 3/1506 (0.2%) | 3 |
| Coronary Artery Occlusion | 1/1506 (0.1%) | 1 |
| Coronary Artery Stenosis | 7/1506 (0.5%) | 7 |
| Coronary Artery Thrombosis | 1/1506 (0.1%) | 1 |
| Coronary Ostial Stenosis | 2/1506 (0.1%) | 2 |
| Dressler's Syndrome | 1/1506 (0.1%) | 1 |
| Ischaemic Cardiomyopathy | 1/1506 (0.1%) | 1 |
| Left Ventricular Dysfunction | 4/1506 (0.3%) | 4 |
| Microvascular Coronary Artery Disease | 1/1506 (0.1%) | 1 |
| Mitral Valve Disease | 1/1506 (0.1%) | 1 |
| Mitral Valve Incompetence | 2/1506 (0.1%) | 2 |
| Myocardial Haemorrhage | 1/1506 (0.1%) | 1 |
| Myocardial Infarction | 12/1506 (0.8%) | 12 |
| Myocardial Ischaemia | 7/1506 (0.5%) | 7 |
| Palpitations | 1/1506 (0.1%) | 1 |
| Pericardial Effusion | 1/1506 (0.1%) | 1 |
| Prosthetic Cardiac Valve Thrombosis | 1/1506 (0.1%) | 1 |
| Pulseless Electrical Activity | 1/1506 (0.1%) | 1 |
| Sinus Node Dysfunction | 7/1506 (0.5%) | 7 |
| Sinus Tachycardia | 1/1506 (0.1%) | 1 |
| Supraventricular Tachycardia | 2/1506 (0.1%) | 2 |
| Tachycardia | 1/1506 (0.1%) | 1 |
| Ventricular Fibrillation | 1/1506 (0.1%) | 1 |
| Ventricular Tachycardia | 5/1506 (0.3%) | 5 |
| Congenital, familial and genetic disorders | ||
| Gastrointestinal Arteriovenous Malformation | 2/1506 (0.1%) | 2 |
| Haemorrhagic Arteriovenous Malformation | 1/1506 (0.1%) | 1 |
| Hypertrophic Cardiomyopathy | 1/1506 (0.1%) | 1 |
| Ear and labyrinth disorders | ||
| Deafness | 1/1506 (0.1%) | 1 |
| Vertigo | 3/1506 (0.2%) | 3 |
| Vestibular Disorder | 1/1506 (0.1%) | 1 |
| Eye disorders | ||
| Blindness Unilateral | 1/1506 (0.1%) | 1 |
| Cataract | 5/1506 (0.3%) | 6 |
| Diabetic Retinopathy | 1/1506 (0.1%) | 1 |
| Eye Ulcer | 1/1506 (0.1%) | 1 |
| Macular Degeneration | 1/1506 (0.1%) | 1 |
| Retinal Artery Occlusion | 1/1506 (0.1%) | 1 |
| Retinal Haemorrhage | 1/1506 (0.1%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal Hernia | 1/1506 (0.1%) | 1 |
| Abdominal Pain | 5/1506 (0.3%) | 5 |
| Abdominal Pain Upper | 2/1506 (0.1%) | 3 |
| Ascites | 1/1506 (0.1%) | 1 |
| Chronic Gastritis | 1/1506 (0.1%) | 1 |
| Colitis | 4/1506 (0.3%) | 4 |
| Colitis Ischaemic | 1/1506 (0.1%) | 1 |
| Constipation | 3/1506 (0.2%) | 3 |
| Crohn's Disease | 1/1506 (0.1%) | 1 |
| Diarrhoea | 3/1506 (0.2%) | 3 |
| Diverticulum | 3/1506 (0.2%) | 3 |
| Diverticulum Intestinal Haemorrhagic | 1/1506 (0.1%) | 3 |
| Duodenal Ulcer Haemorrhage | 1/1506 (0.1%) | 1 |
| Dysphagia | 2/1506 (0.1%) | 2 |
| Enteritis | 1/1506 (0.1%) | 1 |
| Erosive Duodenitis | 1/1506 (0.1%) | 1 |
| Femoral Hernia | 1/1506 (0.1%) | 1 |
| Food Poisoning | 1/1506 (0.1%) | 1 |
| Gastric Perforation | 1/1506 (0.1%) | 1 |
| Gastric Ulcer | 1/1506 (0.1%) | 1 |
| Gastric Ulcer Haemorrhage | 1/1506 (0.1%) | 1 |
| Gastritis | 1/1506 (0.1%) | 1 |
| Gastritis Erosive | 1/1506 (0.1%) | 1 |
| Gastrointestinal Erosion | 1/1506 (0.1%) | 1 |
| Gastrointestinal Haemorrhage | 12/1506 (0.8%) | 12 |
| Gastrooesophageal Reflux Disease | 3/1506 (0.2%) | 3 |
| Haematemesis | 1/1506 (0.1%) | 1 |
| Haematochezia | 1/1506 (0.1%) | 1 |
| Haemorrhagic Ascites | 1/1506 (0.1%) | 1 |
| Haemorrhoids | 1/1506 (0.1%) | 1 |
| Ileus | 1/1506 (0.1%) | 1 |
| Impaired Gastric Emptying | 1/1506 (0.1%) | 1 |
| Incarcerated Inguinal Hernia | 1/1506 (0.1%) | 1 |
| Inguinal Hernia | 4/1506 (0.3%) | 4 |
| Intra-Abdominal Haematoma | 2/1506 (0.1%) | 2 |
| Large Intestine Polyp | 3/1506 (0.2%) | 3 |
| Levator Syndrome | 1/1506 (0.1%) | 1 |
| Lower Gastrointestinal Haemorrhage | 5/1506 (0.3%) | 9 |
| Melaena | 1/1506 (0.1%) | 1 |
| Mesenteric Artery Stenosis | 1/1506 (0.1%) | 1 |
| Mouth Haemorrhage | 1/1506 (0.1%) | 1 |
| Pancreatitis Acute | 1/1506 (0.1%) | 1 |
| Peptic Ulcer | 1/1506 (0.1%) | 1 |
| Pharyngo-Oesophageal Diverticulum | 1/1506 (0.1%) | 1 |
| Small Intestinal Obstruction | 1/1506 (0.1%) | 1 |
| Tooth Impacted | 1/1506 (0.1%) | 2 |
| Umbilical Hernia | 4/1506 (0.3%) | 4 |
| Umbilical Hernia, Obstructive | 1/1506 (0.1%) | 1 |
| Upper Gastrointestinal Haemorrhage | 1/1506 (0.1%) | 1 |
| Varices Oesophageal | 1/1506 (0.1%) | 1 |
| General disorders | ||
| Adverse Drug Reaction | 2/1506 (0.1%) | 2 |
| Asthenia | 1/1506 (0.1%) | 2 |
| Catheter Site Haemorrhage | 2/1506 (0.1%) | 2 |
| Chest Pain | 17/1506 (1.1%) | 18 |
| Death | 15/1506 (1%) | 15 |
| Fatigue | 1/1506 (0.1%) | 1 |
| General Physical Health Deterioration | 1/1506 (0.1%) | 1 |
| Generalised Oedema | 1/1506 (0.1%) | 1 |
| Impaired Healing | 3/1506 (0.2%) | 3 |
| Implant Site Haemorrhage | 1/1506 (0.1%) | 1 |
| Incarcerated Hernia | 1/1506 (0.1%) | 1 |
| Infusion Site Extravasation | 1/1506 (0.1%) | 1 |
| Injection Site Extravasation | 1/1506 (0.1%) | 1 |
| Multiple Organ Dysfunction Syndrome | 2/1506 (0.1%) | 2 |
| Non-Cardiac Chest Pain | 18/1506 (1.2%) | 19 |
| Oedema Peripheral | 1/1506 (0.1%) | 1 |
| Peripheral Swelling | 1/1506 (0.1%) | 1 |
| Physical Deconditioning | 1/1506 (0.1%) | 1 |
| Pyrexia | 5/1506 (0.3%) | 5 |
| Sudden Cardiac Death | 4/1506 (0.3%) | 4 |
| Sudden Death | 2/1506 (0.1%) | 2 |
| Vascular Stent Stenosis | 22/1506 (1.5%) | 22 |
| Vascular Stent Thrombosis | 5/1506 (0.3%) | 5 |
| Hepatobiliary disorders | ||
| Autoimmune Hepatitis | 1/1506 (0.1%) | 1 |
| Bile Duct Obstruction | 1/1506 (0.1%) | 1 |
| Biliary Colic | 1/1506 (0.1%) | 1 |
| Cholecystitis | 3/1506 (0.2%) | 3 |
| Cholecystitis Acute | 1/1506 (0.1%) | 1 |
| Cholelithiasis | 1/1506 (0.1%) | 1 |
| Cholestasis | 2/1506 (0.1%) | 2 |
| Cirrhosis Alcoholic | 2/1506 (0.1%) | 2 |
| Hepatic Cirrhosis | 1/1506 (0.1%) | 1 |
| Hepatic Mass | 1/1506 (0.1%) | 1 |
| Hepatitis Acute | 1/1506 (0.1%) | 1 |
| Non-Alcoholic Steatohepatitis | 1/1506 (0.1%) | 1 |
| Immune system disorders | ||
| Food Allergy | 1/1506 (0.1%) | 1 |
| Hypersensitivity | 1/1506 (0.1%) | 1 |
| Primary Amyloidosis | 1/1506 (0.1%) | 1 |
| Infections and infestations | ||
| Abdominal Sepsis | 1/1506 (0.1%) | 1 |
| Abscess Jaw | 1/1506 (0.1%) | 1 |
| Abscess Limb | 1/1506 (0.1%) | 1 |
| Arthritis Bacterial | 1/1506 (0.1%) | 1 |
| Bacteraemia | 1/1506 (0.1%) | 1 |
| Bacterial Parotitis | 1/1506 (0.1%) | 1 |
| Bronchitis | 4/1506 (0.3%) | 4 |
| Bronchitis Viral | 1/1506 (0.1%) | 1 |
| Carbuncle | 1/1506 (0.1%) | 1 |
| Cellulitis | 8/1506 (0.5%) | 9 |
| Clostridium Difficile Colitis | 1/1506 (0.1%) | 1 |
| Clostridium Difficile Infection | 2/1506 (0.1%) | 2 |
| Cystitis | 1/1506 (0.1%) | 1 |
| Cytomegalovirus Oesophagitis | 1/1506 (0.1%) | 1 |
| Dengue Fever | 1/1506 (0.1%) | 1 |
| Device Related Infection | 2/1506 (0.1%) | 2 |
| Device Related Sepsis | 1/1506 (0.1%) | 1 |
| Diabetic Foot Infection | 1/1506 (0.1%) | 1 |
| Diarrhoea Infectious | 1/1506 (0.1%) | 1 |
| Diverticulitis | 1/1506 (0.1%) | 1 |
| Diverticulitis Intestinal Haemorrhagic | 1/1506 (0.1%) | 1 |
| Endocarditis | 1/1506 (0.1%) | 1 |
| Endocarditis Bacterial | 1/1506 (0.1%) | 1 |
| Endocarditis Enterococcal | 1/1506 (0.1%) | 1 |
| Enterococcal Bacteraemia | 1/1506 (0.1%) | 1 |
| Enterocolitis Fungal | 1/1506 (0.1%) | 1 |
| Escherichia Bacteraemia | 1/1506 (0.1%) | 1 |
| Gangrene | 2/1506 (0.1%) | 3 |
| Gastroenteritis | 6/1506 (0.4%) | 6 |
| Gastrointestinal Infection | 1/1506 (0.1%) | 1 |
| Herpes Zoster | 1/1506 (0.1%) | 1 |
| Hordeolum | 1/1506 (0.1%) | 1 |
| Infected Seroma | 1/1506 (0.1%) | 1 |
| Infected Skin Ulcer | 2/1506 (0.1%) | 2 |
| Infective Exacerbation Of Chronic Obstructive Airways Disease | 1/1506 (0.1%) | 1 |
| Influenza | 1/1506 (0.1%) | 1 |
| Lower Respiratory Tract Infection | 3/1506 (0.2%) | 3 |
| Nosocomial Infection | 1/1506 (0.1%) | 1 |
| Osteomyelitis | 1/1506 (0.1%) | 1 |
| Parainfluenzae Virus Infection | 1/1506 (0.1%) | 1 |
| Pharyngitis | 1/1506 (0.1%) | 1 |
| Pneumonia | 43/1506 (2.9%) | 48 |
| Pneumonia Bacterial | 4/1506 (0.3%) | 4 |
| Pneumonia Klebsiella | 1/1506 (0.1%) | 1 |
| Postoperative Wound Infection | 1/1506 (0.1%) | 1 |
| Pulmonary Sepsis | 3/1506 (0.2%) | 3 |
| Pulmonary Tuberculosis | 1/1506 (0.1%) | 1 |
| Pyelonephritis | 1/1506 (0.1%) | 1 |
| Renal Cyst Infection | 1/1506 (0.1%) | 2 |
| Respiratory Tract Infection | 5/1506 (0.3%) | 6 |
| Respiratory Tract Infection Viral | 1/1506 (0.1%) | 1 |
| Sepsis | 15/1506 (1%) | 16 |
| Septic Shock | 2/1506 (0.1%) | 2 |
| Staphylococcal Bacteraemia | 2/1506 (0.1%) | 2 |
| Streptococcal Bacteraemia | 1/1506 (0.1%) | 1 |
| Tuberculosis | 1/1506 (0.1%) | 1 |
| Upper Respiratory Tract Infection | 2/1506 (0.1%) | 2 |
| Urinary Tract Infection | 20/1506 (1.3%) | 23 |
| Urinary Tract Infection Bacterial | 2/1506 (0.1%) | 2 |
| Urosepsis | 4/1506 (0.3%) | 4 |
| Wound Infection | 1/1506 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Allergic Transfusion Reaction | 1/1506 (0.1%) | 1 |
| Anaemia Postoperative | 3/1506 (0.2%) | 3 |
| Ankle Fracture | 1/1506 (0.1%) | 1 |
| Arteriovenous Fistula Thrombosis | 1/1506 (0.1%) | 1 |
| Cardiac Procedure Complication | 1/1506 (0.1%) | 1 |
| Cardiac Valve Replacement Complication | 1/1506 (0.1%) | 1 |
| Chemical Peritonitis | 1/1506 (0.1%) | 1 |
| Coronary Artery Restenosis | 2/1506 (0.1%) | 2 |
| Costal Cartilage Fracture | 1/1506 (0.1%) | 1 |
| Fall | 2/1506 (0.1%) | 3 |
| Femoral Neck Fracture | 2/1506 (0.1%) | 2 |
| Femur Fracture | 4/1506 (0.3%) | 4 |
| Flail Chest | 1/1506 (0.1%) | 1 |
| Haemodialysis Complication | 1/1506 (0.1%) | 1 |
| Hand Fracture | 1/1506 (0.1%) | 1 |
| Head Injury | 1/1506 (0.1%) | 1 |
| Hip Fracture | 3/1506 (0.2%) | 3 |
| Humerus Fracture | 1/1506 (0.1%) | 1 |
| Incision Site Haematoma | 1/1506 (0.1%) | 1 |
| Joint Dislocation | 1/1506 (0.1%) | 1 |
| Lumbar Vertebral Fracture | 1/1506 (0.1%) | 1 |
| Peripheral Artery Restenosis | 1/1506 (0.1%) | 1 |
| Post Procedural Bile Leak | 1/1506 (0.1%) | 1 |
| Post Procedural Complication | 1/1506 (0.1%) | 1 |
| Post Procedural Haematoma | 1/1506 (0.1%) | 1 |
| Post Procedural Haemorrhage | 4/1506 (0.3%) | 4 |
| Postoperative Hypotension | 1/1506 (0.1%) | 1 |
| Postoperative Ileus | 1/1506 (0.1%) | 1 |
| Postoperative Thoracic Procedure Complication | 1/1506 (0.1%) | 1 |
| Procedural Dizziness | 1/1506 (0.1%) | 1 |
| Procedural Haemorrhage | 2/1506 (0.1%) | 2 |
| Pulmonary Contusion | 1/1506 (0.1%) | 1 |
| Radius Fracture | 2/1506 (0.1%) | 2 |
| Rib Fracture | 3/1506 (0.2%) | 3 |
| Road Traffic Accident | 1/1506 (0.1%) | 1 |
| Skin Laceration | 4/1506 (0.3%) | 4 |
| Spinal Fracture | 1/1506 (0.1%) | 1 |
| Subdural Haematoma | 1/1506 (0.1%) | 1 |
| Toxicity To Various Agents | 2/1506 (0.1%) | 2 |
| Traumatic Intracranial Haemorrhage | 1/1506 (0.1%) | 1 |
| Urinary Tract Stoma Complication | 1/1506 (0.1%) | 1 |
| Vascular Access Site Haemorrhage | 2/1506 (0.1%) | 2 |
| Wound Dehiscence | 1/1506 (0.1%) | 1 |
| Investigations | ||
| Blood Glucose Fluctuation | 1/1506 (0.1%) | 1 |
| Blood Pressure Increased | 1/1506 (0.1%) | 1 |
| Cardiac Output Decreased | 1/1506 (0.1%) | 1 |
| Ejection Fraction Decreased | 3/1506 (0.2%) | 3 |
| Haemoglobin Decreased | 3/1506 (0.2%) | 3 |
| Heparin-Induced Thrombocytopenia Test Positive | 1/1506 (0.1%) | 1 |
| Hepatic Enzyme Increased | 1/1506 (0.1%) | 1 |
| Oxygen Saturation Decreased | 1/1506 (0.1%) | 1 |
| Pulmonary Function Test Decreased | 1/1506 (0.1%) | 1 |
| Stress Echocardiogram Abnormal | 1/1506 (0.1%) | 1 |
| Metabolism and nutrition disorders | ||
| Alcoholic Ketoacidosis | 1/1506 (0.1%) | 1 |
| Dehydration | 2/1506 (0.1%) | 2 |
| Diabetes Mellitus | 2/1506 (0.1%) | 2 |
| Diabetes Mellitus Inadequate Control | 1/1506 (0.1%) | 1 |
| Diabetic Ketoacidosis | 2/1506 (0.1%) | 2 |
| Diabetic Metabolic Decompensation | 1/1506 (0.1%) | 1 |
| Fluid Overload | 2/1506 (0.1%) | 2 |
| Gout | 3/1506 (0.2%) | 3 |
| Hyperglycaemia | 4/1506 (0.3%) | 4 |
| Hyperkalaemia | 4/1506 (0.3%) | 4 |
| Hypokalaemia | 2/1506 (0.1%) | 2 |
| Hypomagnesaemia | 1/1506 (0.1%) | 1 |
| Hyponatraemia | 1/1506 (0.1%) | 1 |
| Iron Deficiency | 1/1506 (0.1%) | 1 |
| Malnutrition | 2/1506 (0.1%) | 2 |
| Mineral Deficiency | 1/1506 (0.1%) | 1 |
| Type 2 Diabetes Mellitus | 1/1506 (0.1%) | 1 |
| Vitamin B12 Deficiency | 1/1506 (0.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 3/1506 (0.2%) | 3 |
| Arthritis | 1/1506 (0.1%) | 1 |
| Back Pain | 2/1506 (0.1%) | 2 |
| Bursitis | 1/1506 (0.1%) | 1 |
| Chest Wall Haematoma | 1/1506 (0.1%) | 1 |
| Flank Pain | 3/1506 (0.2%) | 3 |
| Haematoma Muscle | 1/1506 (0.1%) | 1 |
| Intervertebral Disc Disorder | 1/1506 (0.1%) | 1 |
| Intervertebral Disc Protrusion | 1/1506 (0.1%) | 1 |
| Joint Effusion | 1/1506 (0.1%) | 1 |
| Lumbar Spinal Stenosis | 3/1506 (0.2%) | 3 |
| Muscular Weakness | 1/1506 (0.1%) | 1 |
| Musculoskeletal Chest Pain | 5/1506 (0.3%) | 5 |
| Musculoskeletal Pain | 1/1506 (0.1%) | 1 |
| Myalgia | 1/1506 (0.1%) | 1 |
| Myositis | 1/1506 (0.1%) | 1 |
| Osteoarthritis | 4/1506 (0.3%) | 4 |
| Osteonecrosis | 1/1506 (0.1%) | 1 |
| Pain In Extremity | 3/1506 (0.2%) | 3 |
| Rhabdomyolysis | 1/1506 (0.1%) | 1 |
| Rotator Cuff Syndrome | 1/1506 (0.1%) | 1 |
| Spinal Instability | 1/1506 (0.1%) | 1 |
| Spinal Osteoarthritis | 1/1506 (0.1%) | 1 |
| Spinal Stenosis | 1/1506 (0.1%) | 1 |
| Spondylitis | 1/1506 (0.1%) | 1 |
| Spondylolisthesis | 1/1506 (0.1%) | 1 |
| Systemic Scleroderma | 1/1506 (0.1%) | 1 |
| Trigger Finger | 2/1506 (0.1%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Adenocarcinoma Of Colon | 1/1506 (0.1%) | 1 |
| Adenocarcinoma Pancreas | 1/1506 (0.1%) | 1 |
| Atypical Fibroxanthoma | 1/1506 (0.1%) | 1 |
| Basal Cell Carcinoma | 1/1506 (0.1%) | 1 |
| Bladder Cancer | 3/1506 (0.2%) | 4 |
| Bladder Neoplasm | 5/1506 (0.3%) | 5 |
| Bone Cancer Metastatic | 1/1506 (0.1%) | 1 |
| Brain Neoplasm | 1/1506 (0.1%) | 1 |
| Brain Neoplasm Malignant | 1/1506 (0.1%) | 1 |
| Colon Cancer | 3/1506 (0.2%) | 4 |
| Colon Cancer Metastatic | 1/1506 (0.1%) | 1 |
| Gastrointestinal Adenocarcinoma | 1/1506 (0.1%) | 1 |
| Gastrointestinal Neoplasm | 2/1506 (0.1%) | 2 |
| Glioblastoma | 1/1506 (0.1%) | 1 |
| Hepatic Cancer | 2/1506 (0.1%) | 2 |
| Hepatic Cancer Metastatic | 1/1506 (0.1%) | 1 |
| Hepatocellular Carcinoma | 2/1506 (0.1%) | 2 |
| Hypopharyngeal Cancer | 1/1506 (0.1%) | 1 |
| Lip And/Or Oral Cavity Cancer | 1/1506 (0.1%) | 1 |
| Lung Adenocarcinoma | 1/1506 (0.1%) | 1 |
| Lung Carcinoma Cell Type Unspecified Stage Iv | 1/1506 (0.1%) | 1 |
| Lung Neoplasm | 3/1506 (0.2%) | 3 |
| Lung Neoplasm Malignant | 1/1506 (0.1%) | 1 |
| Malignant Melanoma | 1/1506 (0.1%) | 1 |
| Metastases To Central Nervous System | 1/1506 (0.1%) | 1 |
| Metastatic Malignant Melanoma | 1/1506 (0.1%) | 1 |
| Neoplasm Malignant | 1/1506 (0.1%) | 1 |
| Non-Hodgkin's Lymphoma Stage Iv | 1/1506 (0.1%) | 1 |
| Non-Small Cell Lung Cancer | 1/1506 (0.1%) | 1 |
| Oesophageal Adenocarcinoma | 1/1506 (0.1%) | 1 |
| Oesophageal Cancer Metastatic | 1/1506 (0.1%) | 1 |
| Oesophageal Carcinoma | 1/1506 (0.1%) | 1 |
| Pancreatic Carcinoma | 1/1506 (0.1%) | 1 |
| Parathyroid Tumour Benign | 1/1506 (0.1%) | 1 |
| Plasma Cell Myeloma | 2/1506 (0.1%) | 2 |
| Prostate Cancer | 5/1506 (0.3%) | 5 |
| Prostate Cancer Metastatic | 1/1506 (0.1%) | 1 |
| Renal Cancer | 1/1506 (0.1%) | 1 |
| Transitional Cell Carcinoma | 1/1506 (0.1%) | 1 |
| Nervous system disorders | ||
| Altered State Of Consciousness | 1/1506 (0.1%) | 1 |
| Amputation Stump Pain | 1/1506 (0.1%) | 1 |
| Carotid Artery Occlusion | 1/1506 (0.1%) | 1 |
| Carotid Artery Stenosis | 1/1506 (0.1%) | 1 |
| Carpal Tunnel Syndrome | 1/1506 (0.1%) | 1 |
| Cerebral Haemorrhage | 3/1506 (0.2%) | 3 |
| Cerebral Infarction | 3/1506 (0.2%) | 3 |
| Cerebrovascular Accident | 10/1506 (0.7%) | 11 |
| Cerebrovascular Insufficiency | 1/1506 (0.1%) | 1 |
| Dementia | 1/1506 (0.1%) | 1 |
| Dizziness | 2/1506 (0.1%) | 2 |
| Embolic Stroke | 2/1506 (0.1%) | 2 |
| Encephalopathy | 1/1506 (0.1%) | 1 |
| Epilepsy | 1/1506 (0.1%) | 1 |
| Frontotemporal Dementia | 1/1506 (0.1%) | 1 |
| Haemorrhage Intracranial | 2/1506 (0.1%) | 2 |
| Haemorrhagic Stroke | 1/1506 (0.1%) | 1 |
| Headache | 1/1506 (0.1%) | 1 |
| Hemiparesis | 1/1506 (0.1%) | 1 |
| Hepatic Encephalopathy | 3/1506 (0.2%) | 9 |
| Hypoxic-Ischaemic Encephalopathy | 1/1506 (0.1%) | 1 |
| Ischaemic Stroke | 4/1506 (0.3%) | 4 |
| Lethargy | 2/1506 (0.1%) | 2 |
| Loss Of Consciousness | 2/1506 (0.1%) | 2 |
| Lumbar Radiculopathy | 1/1506 (0.1%) | 1 |
| Metabolic Encephalopathy | 2/1506 (0.1%) | 2 |
| Myelopathy | 1/1506 (0.1%) | 1 |
| Presyncope | 3/1506 (0.2%) | 3 |
| Sciatica | 1/1506 (0.1%) | 1 |
| Seizure | 3/1506 (0.2%) | 3 |
| Stupor | 1/1506 (0.1%) | 1 |
| Subarachnoid Haemorrhage | 1/1506 (0.1%) | 1 |
| Syncope | 11/1506 (0.7%) | 12 |
| Transient Global Amnesia | 1/1506 (0.1%) | 1 |
| Transient Ischaemic Attack | 7/1506 (0.5%) | 7 |
| Vertebrobasilar Stroke | 1/1506 (0.1%) | 1 |
| Product Issues | ||
| Device Capturing Issue | 1/1506 (0.1%) | 1 |
| Device Deposit Issue | 1/1506 (0.1%) | 1 |
| Device Inappropriate Shock Delivery | 1/1506 (0.1%) | 1 |
| Device Loosening | 1/1506 (0.1%) | 1 |
| Device Malfunction | 1/1506 (0.1%) | 1 |
| Lead Dislodgement | 2/1506 (0.1%) | 2 |
| Stent Malfunction | 1/1506 (0.1%) | 1 |
| Psychiatric disorders | ||
| Alcohol Withdrawal Syndrome | 1/1506 (0.1%) | 3 |
| Delirium | 2/1506 (0.1%) | 2 |
| Dissociative Amnesia | 1/1506 (0.1%) | 1 |
| Hallucination, Visual | 1/1506 (0.1%) | 1 |
| Mental Status Changes | 2/1506 (0.1%) | 2 |
| Renal and urinary disorders | ||
| Acute Kidney Injury | 30/1506 (2%) | 34 |
| Azotaemia | 1/1506 (0.1%) | 1 |
| Calculus Urinary | 1/1506 (0.1%) | 1 |
| Chronic Kidney Disease | 2/1506 (0.1%) | 2 |
| Cystitis Haemorrhagic | 1/1506 (0.1%) | 1 |
| Dysuria | 2/1506 (0.1%) | 2 |
| End Stage Renal Disease | 6/1506 (0.4%) | 8 |
| Haematuria | 11/1506 (0.7%) | 11 |
| Hydronephrosis | 1/1506 (0.1%) | 1 |
| Nephrolithiasis | 3/1506 (0.2%) | 3 |
| Nephropathy Toxic | 1/1506 (0.1%) | 1 |
| Renal Cyst Haemorrhage | 1/1506 (0.1%) | 2 |
| Renal Failure | 4/1506 (0.3%) | 4 |
| Renal Haematoma | 1/1506 (0.1%) | 1 |
| Renal Impairment | 4/1506 (0.3%) | 4 |
| Ureterolithiasis | 2/1506 (0.1%) | 2 |
| Urinary Incontinence | 1/1506 (0.1%) | 1 |
| Urinary Retention | 9/1506 (0.6%) | 11 |
| Urinary Tract Obstruction | 1/1506 (0.1%) | 1 |
| Reproductive system and breast disorders | ||
| Benign Prostatic Hyperplasia | 3/1506 (0.2%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute Pulmonary Oedema | 5/1506 (0.3%) | 5 |
| Acute Respiratory Failure | 5/1506 (0.3%) | 5 |
| Asthma | 1/1506 (0.1%) | 1 |
| Atelectasis | 1/1506 (0.1%) | 1 |
| Chronic Obstructive Pulmonary Disease | 13/1506 (0.9%) | 16 |
| Dyspnoea | 7/1506 (0.5%) | 7 |
| Dyspnoea Exertional | 2/1506 (0.1%) | 2 |
| Epistaxis | 10/1506 (0.7%) | 17 |
| Haemoptysis | 1/1506 (0.1%) | 1 |
| Hypoxia | 1/1506 (0.1%) | 1 |
| Interstitial Lung Disease | 1/1506 (0.1%) | 1 |
| Mediastinal Mass | 1/1506 (0.1%) | 1 |
| Pleural Effusion | 11/1506 (0.7%) | 11 |
| Pleuritic Pain | 1/1506 (0.1%) | 1 |
| Pneumonia Aspiration | 4/1506 (0.3%) | 4 |
| Pneumothorax | 3/1506 (0.2%) | 5 |
| Pulmonary Embolism | 3/1506 (0.2%) | 3 |
| Pulmonary Hypertension | 6/1506 (0.4%) | 6 |
| Pulmonary Oedema | 4/1506 (0.3%) | 4 |
| Respiratory Acidosis | 1/1506 (0.1%) | 1 |
| Respiratory Failure | 12/1506 (0.8%) | 14 |
| Skin and subcutaneous tissue disorders | ||
| Actinic Keratosis | 2/1506 (0.1%) | 2 |
| Decubitus Ulcer | 1/1506 (0.1%) | 1 |
| Diabetic Foot | 1/1506 (0.1%) | 1 |
| Pruritus | 1/1506 (0.1%) | 1 |
| Skin Ulcer | 1/1506 (0.1%) | 1 |
| Urticaria | 1/1506 (0.1%) | 1 |
| Surgical and medical procedures | ||
| Colostomy | 1/1506 (0.1%) | 1 |
| Hernia Repair | 1/1506 (0.1%) | 1 |
| Prostatectomy | 1/1506 (0.1%) | 1 |
| Toe Operation | 1/1506 (0.1%) | 2 |
| Vascular disorders | ||
| Aortic Aneurysm | 4/1506 (0.3%) | 4 |
| Aortic Dissection | 1/1506 (0.1%) | 1 |
| Aortic Stenosis | 12/1506 (0.8%) | 12 |
| Arteriosclerosis | 1/1506 (0.1%) | 1 |
| Bleeding Varicose Vein | 1/1506 (0.1%) | 1 |
| Deep Vein Thrombosis | 5/1506 (0.3%) | 5 |
| Dry Gangrene | 2/1506 (0.1%) | 3 |
| Embolism Venous | 1/1506 (0.1%) | 1 |
| Extremity Necrosis | 1/1506 (0.1%) | 1 |
| Haematoma | 3/1506 (0.2%) | 3 |
| Haemodynamic Instability | 1/1506 (0.1%) | 1 |
| Haemorrhage | 2/1506 (0.1%) | 2 |
| Hypertension | 9/1506 (0.6%) | 10 |
| Hypertensive Crisis | 4/1506 (0.3%) | 4 |
| Hypertensive Emergency | 3/1506 (0.2%) | 3 |
| Hypertensive Urgency | 2/1506 (0.1%) | 2 |
| Hypotension | 7/1506 (0.5%) | 8 |
| Hypovolaemic Shock | 1/1506 (0.1%) | 1 |
| Intermittent Claudication | 3/1506 (0.2%) | 3 |
| Orthostatic Hypotension | 2/1506 (0.1%) | 2 |
| Peripheral Arterial Occlusive Disease | 6/1506 (0.4%) | 6 |
| Peripheral Artery Aneurysm | 1/1506 (0.1%) | 1 |
| Peripheral Artery Occlusion | 1/1506 (0.1%) | 1 |
| Peripheral Ischaemia | 6/1506 (0.4%) | 7 |
| Peripheral Vascular Disorder | 7/1506 (0.5%) | 7 |
| Steal Syndrome | 1/1506 (0.1%) | 1 |
| Thrombophlebitis | 1/1506 (0.1%) | 1 |
| Vena Cava Thrombosis | 1/1506 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent | ||
| Affected / at Risk (%) | # Events | |
| Total | 755/1506 (50.1%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 6/1506 (0.4%) | 6 |
| Anaemia Folate Deficiency | 1/1506 (0.1%) | 1 |
| Blood Loss Anaemia | 1/1506 (0.1%) | 1 |
| Febrile Neutropenia | 1/1506 (0.1%) | 1 |
| Haemorrhagic Disorder | 1/1506 (0.1%) | 1 |
| Lymphadenopathy | 1/1506 (0.1%) | 1 |
| Schistocytosis | 1/1506 (0.1%) | 1 |
| Thrombotic Thrombocytopenic Purpura | 1/1506 (0.1%) | 1 |
| Cardiac disorders | ||
| Acute Myocardial Infarction | 3/1506 (0.2%) | 3 |
| Angina Pectoris | 29/1506 (1.9%) | 32 |
| Angina Unstable | 2/1506 (0.1%) | 2 |
| Anginal Equivalent | 1/1506 (0.1%) | 1 |
| Arrhythmia | 2/1506 (0.1%) | 2 |
| Atrial Fibrillation | 14/1506 (0.9%) | 14 |
| Atrial Flutter | 2/1506 (0.1%) | 2 |
| Atrioventricular Block | 1/1506 (0.1%) | 1 |
| Atrioventricular Block First Degree | 3/1506 (0.2%) | 3 |
| Bradycardia | 3/1506 (0.2%) | 3 |
| Bundle Branch Block Left | 1/1506 (0.1%) | 1 |
| Bundle Branch Block Right | 1/1506 (0.1%) | 1 |
| Cardiac Failure | 9/1506 (0.6%) | 9 |
| Cardiac Failure Chronic | 1/1506 (0.1%) | 1 |
| Cardiac Failure Congestive | 1/1506 (0.1%) | 1 |
| Cardiac Valve Disease | 1/1506 (0.1%) | 1 |
| Defect Conduction Intraventricular | 1/1506 (0.1%) | 1 |
| Intracardiac Thrombus | 1/1506 (0.1%) | 1 |
| Mitral Valve Incompetence | 1/1506 (0.1%) | 1 |
| Myocardial Infarction | 1/1506 (0.1%) | 1 |
| Palpitations | 4/1506 (0.3%) | 4 |
| Sinus Tachycardia | 1/1506 (0.1%) | 1 |
| Tricuspid Valve Incompetence | 1/1506 (0.1%) | 1 |
| Congenital, familial and genetic disorders | ||
| Phimosis | 1/1506 (0.1%) | 1 |
| Ear and labyrinth disorders | ||
| Hypoacusis | 1/1506 (0.1%) | 1 |
| Vertigo | 2/1506 (0.1%) | 2 |
| Vertigo Positional | 2/1506 (0.1%) | 2 |
| Eye disorders | ||
| Cataract | 2/1506 (0.1%) | 2 |
| Conjunctival Haemorrhage | 4/1506 (0.3%) | 5 |
| Diplopia | 1/1506 (0.1%) | 1 |
| Eye Haemorrhage | 1/1506 (0.1%) | 1 |
| Eye Pain | 1/1506 (0.1%) | 1 |
| Lacrimation Increased | 1/1506 (0.1%) | 1 |
| Vitreous Haemorrhage | 1/1506 (0.1%) | 2 |
| Gastrointestinal disorders | ||
| Abdominal Discomfort | 1/1506 (0.1%) | 1 |
| Abdominal Pain | 6/1506 (0.4%) | 6 |
| Abdominal Pain Lower | 1/1506 (0.1%) | 1 |
| Abdominal Pain Upper | 3/1506 (0.2%) | 3 |
| Anal Haemorrhage | 1/1506 (0.1%) | 1 |
| Anal Stenosis | 1/1506 (0.1%) | 1 |
| Appendicolith | 1/1506 (0.1%) | 1 |
| Atrophic Glossitis | 1/1506 (0.1%) | 1 |
| Constipation | 6/1506 (0.4%) | 7 |
| Dental Caries | 1/1506 (0.1%) | 1 |
| Diarrhoea | 8/1506 (0.5%) | 8 |
| Diverticulum | 1/1506 (0.1%) | 1 |
| Diverticulum Intestinal | 1/1506 (0.1%) | 1 |
| Dyschezia | 1/1506 (0.1%) | 1 |
| Dyspepsia | 3/1506 (0.2%) | 3 |
| Dysphagia | 1/1506 (0.1%) | 1 |
| Gastritis | 3/1506 (0.2%) | 4 |
| Gastrointestinal Haemorrhage | 2/1506 (0.1%) | 2 |
| Gastrooesophageal Reflux Disease | 3/1506 (0.2%) | 3 |
| Gingival Bleeding | 1/1506 (0.1%) | 1 |
| Gingival Hypertrophy | 1/1506 (0.1%) | 1 |
| Haematochezia | 1/1506 (0.1%) | 1 |
| Inguinal Hernia | 1/1506 (0.1%) | 1 |
| Large Intestine Polyp | 1/1506 (0.1%) | 1 |
| Lower Gastrointestinal Haemorrhage | 1/1506 (0.1%) | 1 |
| Melaena | 1/1506 (0.1%) | 1 |
| Nausea | 5/1506 (0.3%) | 6 |
| Rectal Haemorrhage | 5/1506 (0.3%) | 5 |
| Tongue Disorder | 1/1506 (0.1%) | 1 |
| Tongue Haemorrhage | 3/1506 (0.2%) | 4 |
| Toothache | 1/1506 (0.1%) | 1 |
| Umbilical Hernia | 1/1506 (0.1%) | 1 |
| Vomiting | 1/1506 (0.1%) | 1 |
| General disorders | ||
| Adverse Drug Reaction | 2/1506 (0.1%) | 2 |
| Asthenia | 2/1506 (0.1%) | 2 |
| Catheter Site Haematoma | 1/1506 (0.1%) | 1 |
| Catheter Site Haemorrhage | 1/1506 (0.1%) | 1 |
| Chest Discomfort | 9/1506 (0.6%) | 9 |
| Chest Pain | 28/1506 (1.9%) | 28 |
| Drug Intolerance | 1/1506 (0.1%) | 1 |
| Exercise Tolerance Decreased | 1/1506 (0.1%) | 1 |
| Fatigue | 8/1506 (0.5%) | 8 |
| Hangover | 1/1506 (0.1%) | 1 |
| Malaise | 2/1506 (0.1%) | 3 |
| Non-Cardiac Chest Pain | 21/1506 (1.4%) | 22 |
| Oedema Peripheral | 7/1506 (0.5%) | 7 |
| Pain | 1/1506 (0.1%) | 1 |
| Peripheral Swelling | 2/1506 (0.1%) | 2 |
| Puncture Site Haematoma | 1/1506 (0.1%) | 1 |
| Pyrexia | 2/1506 (0.1%) | 2 |
| Hepatobiliary disorders | ||
| Biliary Colic | 1/1506 (0.1%) | 1 |
| Cholelithiasis | 2/1506 (0.1%) | 2 |
| Cholestasis | 1/1506 (0.1%) | 1 |
| Hepatic Lesion | 1/1506 (0.1%) | 1 |
| Hepatic Steatosis | 1/1506 (0.1%) | 1 |
| Nonalcoholic Fatty Liver Disease | 1/1506 (0.1%) | 1 |
| Immune system disorders | ||
| Contrast Media Allergy | 1/1506 (0.1%) | 1 |
| Infections and infestations | ||
| Bronchitis | 4/1506 (0.3%) | 4 |
| Cellulitis | 5/1506 (0.3%) | 6 |
| Chronic Hepatitis C | 1/1506 (0.1%) | 1 |
| Conjunctivitis | 2/1506 (0.1%) | 2 |
| Cystitis | 1/1506 (0.1%) | 1 |
| Ear Infection | 1/1506 (0.1%) | 1 |
| Fungal Skin Infection | 1/1506 (0.1%) | 2 |
| Furuncle | 1/1506 (0.1%) | 1 |
| Gastroenteritis | 1/1506 (0.1%) | 1 |
| Gastrointestinal Infection | 1/1506 (0.1%) | 1 |
| Helicobacter Infection | 1/1506 (0.1%) | 1 |
| Infected Skin Ulcer | 1/1506 (0.1%) | 1 |
| Influenza | 2/1506 (0.1%) | 2 |
| Lower Respiratory Tract Infection | 2/1506 (0.1%) | 2 |
| Lung Infection | 1/1506 (0.1%) | 1 |
| Nasopharyngitis | 2/1506 (0.1%) | 2 |
| Necrotising Soft Tissue Infection | 1/1506 (0.1%) | 1 |
| Oral Candidiasis | 1/1506 (0.1%) | 1 |
| Orchitis | 1/1506 (0.1%) | 1 |
| Pharyngitis | 2/1506 (0.1%) | 2 |
| Pneumonia | 5/1506 (0.3%) | 5 |
| Postoperative Wound Infection | 1/1506 (0.1%) | 1 |
| Pyelonephritis | 1/1506 (0.1%) | 1 |
| Respiratory Tract Infection | 3/1506 (0.2%) | 3 |
| Rhinitis | 1/1506 (0.1%) | 1 |
| Tonsillitis | 1/1506 (0.1%) | 1 |
| Tooth Abscess | 1/1506 (0.1%) | 1 |
| Upper Respiratory Tract Infection | 6/1506 (0.4%) | 6 |
| Urinary Tract Infection | 10/1506 (0.7%) | 10 |
| Viral Upper Respiratory Tract Infection | 1/1506 (0.1%) | 1 |
| Vulvovaginal Candidiasis | 1/1506 (0.1%) | 1 |
| Wound Sepsis | 1/1506 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Arteriovenous Fistula Site Haemorrhage | 1/1506 (0.1%) | 1 |
| Arteriovenous Graft Site Haemorrhage | 1/1506 (0.1%) | 1 |
| Clavicle Fracture | 1/1506 (0.1%) | 1 |
| Contusion | 16/1506 (1.1%) | 19 |
| Eye Injury | 1/1506 (0.1%) | 1 |
| Fall | 4/1506 (0.3%) | 4 |
| Femur Fracture | 1/1506 (0.1%) | 1 |
| Head Injury | 1/1506 (0.1%) | 1 |
| Humerus Fracture | 2/1506 (0.1%) | 2 |
| Incision Site Haemorrhage | 2/1506 (0.1%) | 2 |
| Ligament Sprain | 1/1506 (0.1%) | 1 |
| Limb Injury | 3/1506 (0.2%) | 3 |
| Muscle Injury | 1/1506 (0.1%) | 1 |
| Muscle Strain | 2/1506 (0.1%) | 2 |
| Patella Fracture | 1/1506 (0.1%) | 1 |
| Periorbital Haemorrhage | 1/1506 (0.1%) | 1 |
| Plaque Shift | 1/1506 (0.1%) | 2 |
| Post Procedural Haematoma | 1/1506 (0.1%) | 1 |
| Post Procedural Haematuria | 1/1506 (0.1%) | 1 |
| Post Procedural Haemorrhage | 1/1506 (0.1%) | 1 |
| Postoperative Hypertension | 1/1506 (0.1%) | 1 |
| Rib Fracture | 2/1506 (0.1%) | 2 |
| Skin Abrasion | 3/1506 (0.2%) | 3 |
| Skin Injury | 1/1506 (0.1%) | 1 |
| Skin Laceration | 10/1506 (0.7%) | 10 |
| Spinal Compression Fracture | 2/1506 (0.1%) | 2 |
| Subdural Haematoma | 1/1506 (0.1%) | 1 |
| Tooth Fracture | 1/1506 (0.1%) | 1 |
| Toxicity To Various Agents | 1/1506 (0.1%) | 1 |
| Traumatic Haematoma | 3/1506 (0.2%) | 3 |
| Upper Limb Fracture | 1/1506 (0.1%) | 1 |
| Vascular Access Site Bruising | 1/1506 (0.1%) | 1 |
| Vascular Access Site Haematoma | 2/1506 (0.1%) | 2 |
| Vascular Access Site Haemorrhage | 2/1506 (0.1%) | 2 |
| Vascular Access Site Pseudoaneurysm | 1/1506 (0.1%) | 1 |
| Wound | 1/1506 (0.1%) | 1 |
| Wound Haemorrhage | 1/1506 (0.1%) | 1 |
| Investigations | ||
| Aortic Bruit | 1/1506 (0.1%) | 1 |
| Blood Creatinine Increased | 1/1506 (0.1%) | 1 |
| Blood Pressure Increased | 2/1506 (0.1%) | 2 |
| Haemoglobin Decreased | 1/1506 (0.1%) | 1 |
| International Normalised Ratio Abnormal | 1/1506 (0.1%) | 1 |
| Liver Function Test Abnormal | 1/1506 (0.1%) | 1 |
| Nutritional Condition Normal | 1/1506 (0.1%) | 1 |
| Occult Blood | 2/1506 (0.1%) | 2 |
| Occult Blood Positive | 1/1506 (0.1%) | 1 |
| Troponin Increased | 1/1506 (0.1%) | 1 |
| Venous Pressure Jugular Increased | 1/1506 (0.1%) | 1 |
| Vitamin B12 Decreased | 1/1506 (0.1%) | 1 |
| Metabolism and nutrition disorders | ||
| Calcium Deficiency | 1/1506 (0.1%) | 1 |
| Decreased Appetite | 1/1506 (0.1%) | 1 |
| Diabetes Mellitus | 2/1506 (0.1%) | 2 |
| Electrolyte Imbalance | 1/1506 (0.1%) | 1 |
| Fluid Overload | 1/1506 (0.1%) | 1 |
| Gout | 1/1506 (0.1%) | 1 |
| Hyperglycaemia | 6/1506 (0.4%) | 6 |
| Hyperkalaemia | 1/1506 (0.1%) | 1 |
| Hyperuricaemia | 1/1506 (0.1%) | 1 |
| Hypoglycaemia | 2/1506 (0.1%) | 2 |
| Hypomagnesaemia | 1/1506 (0.1%) | 1 |
| Iron Deficiency | 2/1506 (0.1%) | 2 |
| Vitamin D Deficiency | 1/1506 (0.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 11/1506 (0.7%) | 11 |
| Arthritis | 1/1506 (0.1%) | 1 |
| Back Pain | 6/1506 (0.4%) | 6 |
| Chondrocalcinosis Pyrophosphate | 1/1506 (0.1%) | 1 |
| Haemarthrosis | 2/1506 (0.1%) | 2 |
| Joint Effusion | 1/1506 (0.1%) | 1 |
| Joint Swelling | 1/1506 (0.1%) | 1 |
| Metatarsalgia | 1/1506 (0.1%) | 1 |
| Mobility Decreased | 1/1506 (0.1%) | 1 |
| Muscle Spasms | 1/1506 (0.1%) | 1 |
| Muscular Weakness | 1/1506 (0.1%) | 1 |
| Musculoskeletal Chest Pain | 7/1506 (0.5%) | 7 |
| Musculoskeletal Pain | 2/1506 (0.1%) | 2 |
| Myalgia | 1/1506 (0.1%) | 1 |
| Neck Mass | 1/1506 (0.1%) | 1 |
| Osteoarthritis | 2/1506 (0.1%) | 2 |
| Osteoporosis | 1/1506 (0.1%) | 1 |
| Pain In Extremity | 8/1506 (0.5%) | 8 |
| Pain In Jaw | 1/1506 (0.1%) | 1 |
| Polymyalgia Rheumatica | 1/1506 (0.1%) | 1 |
| Rotator Cuff Syndrome | 2/1506 (0.1%) | 2 |
| Sarcopenia | 1/1506 (0.1%) | 1 |
| Sjogren's Syndrome | 1/1506 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Myolipoma | 1/1506 (0.1%) | 1 |
| Squamous Cell Carcinoma Of Skin | 1/1506 (0.1%) | 1 |
| Nervous system disorders | ||
| Akinesia | 1/1506 (0.1%) | 1 |
| Amnesia | 1/1506 (0.1%) | 1 |
| Balance Disorder | 1/1506 (0.1%) | 1 |
| Carotid Artery Stenosis | 1/1506 (0.1%) | 1 |
| Cerebral Ischaemia | 1/1506 (0.1%) | 1 |
| Cognitive Disorder | 3/1506 (0.2%) | 3 |
| Corticobasal Degeneration | 1/1506 (0.1%) | 1 |
| Dizziness | 8/1506 (0.5%) | 9 |
| Focal Dyscognitive Seizures | 1/1506 (0.1%) | 1 |
| Headache | 8/1506 (0.5%) | 9 |
| Hypoaesthesia | 2/1506 (0.1%) | 2 |
| Hypotonia | 2/1506 (0.1%) | 2 |
| Migraine | 3/1506 (0.2%) | 3 |
| Polyneuropathy | 1/1506 (0.1%) | 1 |
| Sciatica | 2/1506 (0.1%) | 2 |
| Syncope | 6/1506 (0.4%) | 6 |
| Tension Headache | 1/1506 (0.1%) | 1 |
| Tonic Convulsion | 1/1506 (0.1%) | 1 |
| Transient Ischaemic Attack | 4/1506 (0.3%) | 4 |
| Visual Field Defect | 1/1506 (0.1%) | 1 |
| Product Issues | ||
| Device Malfunction | 1/1506 (0.1%) | 1 |
| Psychiatric disorders | ||
| Confusional State | 1/1506 (0.1%) | 1 |
| Delirium | 3/1506 (0.2%) | 3 |
| Depression | 1/1506 (0.1%) | 1 |
| Insomnia | 1/1506 (0.1%) | 1 |
| Psychotic Disorder Due To A General Medical Condition | 1/1506 (0.1%) | 1 |
| Renal and urinary disorders | ||
| Acute Kidney Injury | 5/1506 (0.3%) | 5 |
| Bladder Dilatation | 1/1506 (0.1%) | 1 |
| Calculus Bladder | 1/1506 (0.1%) | 1 |
| Chronic Kidney Disease | 6/1506 (0.4%) | 6 |
| Dysuria | 2/1506 (0.1%) | 2 |
| Haematuria | 21/1506 (1.4%) | 22 |
| Nocturia | 1/1506 (0.1%) | 1 |
| Pollakiuria | 1/1506 (0.1%) | 1 |
| Renal Failure | 1/1506 (0.1%) | 1 |
| Renal Impairment | 1/1506 (0.1%) | 1 |
| Renal Mass | 2/1506 (0.1%) | 2 |
| Urethral Haemorrhage | 1/1506 (0.1%) | 1 |
| Urethral Perforation | 1/1506 (0.1%) | 1 |
| Urinary Bladder Haemorrhage | 1/1506 (0.1%) | 1 |
| Urinary Incontinence | 1/1506 (0.1%) | 1 |
| Urinary Retention | 1/1506 (0.1%) | 1 |
| Urogenital Haemorrhage | 1/1506 (0.1%) | 1 |
| Reproductive system and breast disorders | ||
| Adnexa Uteri Mass | 1/1506 (0.1%) | 1 |
| Postmenopausal Haemorrhage | 1/1506 (0.1%) | 1 |
| Vaginal Haemorrhage | 1/1506 (0.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Apnoea | 1/1506 (0.1%) | 1 |
| Asthma | 2/1506 (0.1%) | 2 |
| Chronic Obstructive Pulmonary Disease | 5/1506 (0.3%) | 5 |
| Cough | 5/1506 (0.3%) | 5 |
| Dyspnoea | 14/1506 (0.9%) | 17 |
| Dyspnoea Exertional | 3/1506 (0.2%) | 3 |
| Epistaxis | 20/1506 (1.3%) | 23 |
| Haemoptysis | 3/1506 (0.2%) | 3 |
| Haemothorax | 1/1506 (0.1%) | 1 |
| Nasal Crusting | 1/1506 (0.1%) | 1 |
| Nocturnal Dyspnoea | 1/1506 (0.1%) | 1 |
| Oropharyngeal Pain | 1/1506 (0.1%) | 1 |
| Orthopnoea | 1/1506 (0.1%) | 1 |
| Pleural Effusion | 2/1506 (0.1%) | 2 |
| Productive Cough | 1/1506 (0.1%) | 1 |
| Pulmonary Mass | 1/1506 (0.1%) | 1 |
| Sleep Apnoea Syndrome | 2/1506 (0.1%) | 2 |
| Upper-Airway Cough Syndrome | 1/1506 (0.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Actinic Keratosis | 3/1506 (0.2%) | 3 |
| Dermal Cyst | 1/1506 (0.1%) | 1 |
| Dermatitis | 1/1506 (0.1%) | 1 |
| Dermatitis Atopic | 1/1506 (0.1%) | 1 |
| Ecchymosis | 8/1506 (0.5%) | 8 |
| Eczema | 1/1506 (0.1%) | 1 |
| Ingrowing Nail | 1/1506 (0.1%) | 1 |
| Nail Bed Bleeding | 1/1506 (0.1%) | 1 |
| Petechiae | 2/1506 (0.1%) | 2 |
| Rash | 3/1506 (0.2%) | 3 |
| Rash Maculo-Papular | 1/1506 (0.1%) | 1 |
| Skin Lesion | 1/1506 (0.1%) | 1 |
| Skin Necrosis | 1/1506 (0.1%) | 1 |
| Skin Ulcer Haemorrhage | 1/1506 (0.1%) | 1 |
| Spider Naevus | 1/1506 (0.1%) | 1 |
| Surgical and medical procedures | ||
| Cerumen Removal | 1/1506 (0.1%) | 1 |
| Skin Neoplasm Excision | 1/1506 (0.1%) | 1 |
| Vascular disorders | ||
| Aortic Stenosis | 1/1506 (0.1%) | 1 |
| Deep Vein Thrombosis | 1/1506 (0.1%) | 1 |
| Extremity Necrosis | 1/1506 (0.1%) | 1 |
| Haematoma | 6/1506 (0.4%) | 6 |
| Hypertension | 10/1506 (0.7%) | 12 |
| Hypertensive Crisis | 2/1506 (0.1%) | 2 |
| Hypertensive Emergency | 1/1506 (0.1%) | 1 |
| Hypotension | 4/1506 (0.3%) | 4 |
| Intermittent Claudication | 2/1506 (0.1%) | 2 |
| Jugular Vein Thrombosis | 1/1506 (0.1%) | 1 |
| Labile Blood Pressure | 2/1506 (0.1%) | 2 |
| Orthostatic Hypotension | 3/1506 (0.2%) | 3 |
| Subclavian Vein Thrombosis | 1/1506 (0.1%) | 1 |
| Thrombophlebitis Superficial | 1/1506 (0.1%) | 1 |
| Varicose Vein Ruptured | 1/1506 (0.1%) | 1 |
| Venous Stenosis | 1/1506 (0.1%) | 1 |
| Venous Thrombosis | 1/1506 (0.1%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Cecile Mahoney, Sr. Clinical Research Specialist |
|---|---|
| Organization | Medtronic Coronary/Renal Denervation (C/RDN) |
| Phone | 763-505-1057 |
| cecile.c.mahoney@medtronic.com |
Responsible Party:
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT03647475
Other Study ID Numbers:
- MDT18015RES008
First Posted:
Aug 27, 2018
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021