Trial Outcomes & Findings for BIOHELIX-I Bare Metal Stent Study (NCT NCT01612767)
NCT ID: NCT01612767
Last Updated: 2018-09-28
Results Overview
The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
329 participants
Primary outcome timeframe
9 months post-index procedure
Results posted on
2018-09-28
Participant Flow
Participant milestones
| Measure |
Pro-Kinetic Energy Stent
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|
|
Overall Study
STARTED
|
329
|
|
Overall Study
COMPLETED
|
287
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BIOHELIX-I Bare Metal Stent Study
Baseline characteristics by cohort
| Measure |
Pro-Kinetic Energy Stent
n=329 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|
|
Age, Continuous
|
69.0 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
306 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
305 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
215 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
88 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
1 Participants
n=5 Participants
|
|
Medical History
Diabetes
|
94 Participants
n=5 Participants
|
|
Medical History
Hypertension
|
276 Participants
n=5 Participants
|
|
Medical History
Hyperlipidemia
|
240 Participants
n=5 Participants
|
|
Medical History
Current smoker
|
60 Participants
n=5 Participants
|
|
Medical History
Smoked within last 5 years
|
31 Participants
n=5 Participants
|
|
Medical History
Never smoked or not within last 5 years
|
238 Participants
n=5 Participants
|
|
Medical History
History of myocardial infarction (MI)
|
67 Participants
n=5 Participants
|
|
Medical History
Prior coronary artery bypass graft (CABG)
|
27 Participants
n=5 Participants
|
|
Medical History
Prior percutaneous coronary revascularization
|
100 Participants
n=5 Participants
|
|
Medical History
Renal insufficiency
|
8 Participants
n=5 Participants
|
|
Concomitant Medications
Dual Antiplatelet Therapy (DAPT)
|
96 Participants
n=5 Participants
|
|
Concomitant Medications
Aspirin
|
260 Participants
n=5 Participants
|
|
Concomitant Medications
Antiplatelet - Clopidogrel
|
79 Participants
n=5 Participants
|
|
Concomitant Medications
Antiplatelet - Prasugrel
|
9 Participants
n=5 Participants
|
|
Concomitant Medications
Antiplatelet - Ticagrelor
|
15 Participants
n=5 Participants
|
|
Concomitant Medications
Antiotensin-converting-enzyme (ACE) inhibitor
|
135 Participants
n=5 Participants
|
|
Concomitant Medications
Angiotensin II receptor blocker
|
78 Participants
n=5 Participants
|
|
Concomitant Medications
Beta blocker
|
203 Participants
n=5 Participants
|
|
Concomitant Medications
Statins
|
213 Participants
n=5 Participants
|
|
Concomitant Medications
Insulin
|
37 Participants
n=5 Participants
|
|
Concomitant Medications
Anti-coagulant
|
32 Participants
n=5 Participants
|
|
Lesion Location
Left Anterior Descending (LAD)
|
122 Participants
n=5 Participants
|
|
Lesion Location
Circumflex
|
82 Participants
n=5 Participants
|
|
Lesion Location
Right
|
125 Participants
n=5 Participants
|
|
Lesion Length
|
13.7 mm
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Vessel Diameter
Pre-deployment target vessel MLD
|
0.9 mm
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Vessel Diameter
Pre-deployment target vessel reference diameter
|
2.9 mm
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Vessel Diameter
Post-deployment target vessel MLD
|
3.1 mm
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Lesion Calcification
None
|
245 Participants
n=5 Participants
|
|
Lesion Calcification
Moderate
|
58 Participants
n=5 Participants
|
|
Lesion Calcification
Severe
|
26 Participants
n=5 Participants
|
|
Thrombolysis in Myocardial Infarction (TIMI) Flow
0
|
1 Participants
n=5 Participants
|
|
Thrombolysis in Myocardial Infarction (TIMI) Flow
1
|
6 Participants
n=5 Participants
|
|
Thrombolysis in Myocardial Infarction (TIMI) Flow
2
|
24 Participants
n=5 Participants
|
|
Thrombolysis in Myocardial Infarction (TIMI) Flow
3
|
298 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 months post-index procedureThe primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=320 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Target Vessel Failure Rate
Overall Target Vessel Failure Rate
|
9.06 Percentage of participants
Interval 6.15 to 12.76
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Target Vessel Failure Rate
Cardiac death
|
0.95 Percentage of participants
Interval 0.2 to 2.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Target Vessel Failure Rate
Myocardial infarction
|
1.58 Percentage of participants
Interval 0.52 to 3.65
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Target Vessel Failure Rate
Ischemia-driven target vessel revascularization
|
7.26 Percentage of participants
Interval 4.65 to 10.69
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 12, 24 and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=327 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Target Vessel Failure Rate
1 Month
|
1.22 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Target Vessel Failure Rate
12 Months
|
10.76 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Target Vessel Failure Rate
24 Months
|
13.26 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Target Vessel Failure Rate
36 Months
|
17.61 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 12, 24 and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=327 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=316 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=309 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=301 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Target Vessel Failure Rate - Contribution of Individual Event Types
Cardiac death
|
0.00 Percentage of participants
|
0.96 Percentage of participants
|
2.30 Percentage of participants
|
4.07 Percentage of participants
|
—
|
—
|
—
|
|
Target Vessel Failure Rate - Contribution of Individual Event Types
Myocardial infarction
|
0.61 Percentage of participants
|
1.61 Percentage of participants
|
2.00 Percentage of participants
|
3.50 Percentage of participants
|
—
|
—
|
—
|
|
Target Vessel Failure Rate - Contribution of Individual Event Types
Ischemia-driven target vessel revascularization
|
0.61 Percentage of participants
|
8.97 Percentage of participants
|
10.23 Percentage of participants
|
12.46 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 9, 12, 24 and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=327 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=318 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=312 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=303 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=289 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Overall Target Vessel Revascularization Rate
|
0.61 Percentage of participants
|
7.86 Percentage of participants
|
9.62 Percentage of participants
|
11.55 Percentage of participants
|
13.84 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 9, 12, 24 and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=327 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=321 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=315 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=308 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=300 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Overall Target Lesion Failure Rate
|
1.22 Percentage of participants
|
8.41 Percentage of participants
|
9.84 Percentage of participants
|
11.68 Percentage of participants
|
15.33 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 9, 12, 24, and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=327 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=321 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=315 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=308 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=300 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Target Lesion Failure Rate - Contribution of Individual Event Types
Cardiac death
|
0.00 Percentage of participants
|
0.95 Percentage of participants
|
0.96 Percentage of participants
|
2.30 Percentage of participants
|
4.07 Percentage of participants
|
—
|
—
|
|
Target Lesion Failure Rate - Contribution of Individual Event Types
Myocardial infarction
|
0.61 Percentage of participants
|
1.58 Percentage of participants
|
1.61 Percentage of participants
|
2.00 Percentage of participants
|
3.50 Percentage of participants
|
—
|
—
|
|
Target Lesion Failure Rate - Contribution of Individual Event Types
Ischemia-driven target vessel revascularization
|
0.61 Percentage of participants
|
6.60 Percentage of participants
|
8.04 Percentage of participants
|
8.61 Percentage of participants
|
10.07 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 9, 12, 24 and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=327 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=318 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=312 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=303 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=289 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Overall Target Lesion Revascularization Rate
|
0.61 Percentage of participants
|
7.23 Percentage of participants
|
8.65 Percentage of participants
|
9.24 Percentage of participants
|
10.37 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 9, 12, 24, and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=326 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=321 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=317 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=314 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=311 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Composite of All-cause Mortality and All-cause MI
|
0.61 Percentage of participants
|
3.12 Percentage of participants
|
3.79 Percentage of participants
|
7.32 Percentage of participants
|
11.25 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 9, 12, 24, and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=326 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=321 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=317 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=314 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=311 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
All-cause Mortality and All-cause MI - Contribution of Individual Rates
All-cause mortality
|
0.00 Percentage of participants
|
1.87 Percentage of participants
|
2.52 Percentage of participants
|
5.73 Percentage of participants
|
8.68 Percentage of participants
|
—
|
—
|
|
All-cause Mortality and All-cause MI - Contribution of Individual Rates
Cardiac mortality
|
0.00 Percentage of participants
|
0.93 Percentage of participants
|
0.95 Percentage of participants
|
2.23 Percentage of participants
|
3.86 Percentage of participants
|
—
|
—
|
|
All-cause Mortality and All-cause MI - Contribution of Individual Rates
Non-cardiac mortality
|
0.00 Percentage of participants
|
0.93 Percentage of participants
|
1.58 Percentage of participants
|
3.50 Percentage of participants
|
4.82 Percentage of participants
|
—
|
—
|
|
All-cause Mortality and All-cause MI - Contribution of Individual Rates
All-cause MI
|
0.61 Percentage of participants
|
1.56 Percentage of participants
|
1.58 Percentage of participants
|
1.91 Percentage of participants
|
3.22 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 9, 12, 24 and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=327 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=319 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=313 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=305 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=293 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Stent Thrombosis Rate
Definite stent thrombosis
|
0.3 Percentage of participants
|
0.9 Percentage of participants
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
1.4 Percentage of participants
|
—
|
—
|
|
Stent Thrombosis Rate
Probable stent thrombosis
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
—
|
—
|
|
Stent Thrombosis Rate
Total definite / probable stent thrombosis
|
0.3 Percentage of participants
|
1.3 Percentage of participants
|
1.3 Percentage of participants
|
1.3 Percentage of participants
|
1.7 Percentage of participants
|
—
|
—
|
|
Stent Thrombosis Rate
Possible stent thrombosis
|
0.0 Percentage of participants
|
0.9 Percentage of participants
|
1.0 Percentage of participants
|
1.6 Percentage of participants
|
2.7 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Index procedureEvaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of \< 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=329 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Index Procedure Success
|
98.8 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Index procedureEvaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of \< 30% by operator visual estimate.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=329 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Device Success During the Index Procedure
|
99.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Index procedureEvaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of \< 30% by operator visual estimate.
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=329 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Lesion Success During the Index Procedure
|
99.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedurePopulation: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Evaluate the angina pectoris classification at each study visit. Stable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest Unstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction
Outcome measures
| Measure |
Pro-Kinetic Energy Stent
n=329 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 12 Months
n=329 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Months
n=326 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Months
n=307 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=303 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 24 Month
n=296 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
PRO-Kinetic Energy Stent - 36 Month
n=283 Participants
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|---|---|---|---|---|---|
|
Angina Pectoris Classification
Unstable Angine Class IIIC
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Angina Pectoris Classification
Unstable Angine Class IA
|
1.5 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Angina Pectoris Classification
Unstable Angine Class IB
|
1.8 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Angina Pectoris Classification
Unstable Angine Class IC
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Angina Pectoris Classification
Unstable Angine Class IIA
|
2.7 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Angina Pectoris Classification
Unstable Angine Class IIB
|
2.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Angina Pectoris Classification
Unstable Angine Class IIC
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Angina Pectoris Classification
Unstable Angine Class IIIA
|
1.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Angina Pectoris Classification
Unstable Angine Class IIIB
|
3.0 Percentage of participants
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Angina Pectoris Classification
No Angina
|
25.8 Percentage of participants
|
97.3 Percentage of participants
|
93.9 Percentage of participants
|
88.9 Percentage of participants
|
94.7 Percentage of participants
|
95.3 Percentage of participants
|
94.3 Percentage of participants
|
|
Angina Pectoris Classification
Total Stable Angina
|
61.7 Percentage of participants
|
2.4 Percentage of participants
|
5.8 Percentage of participants
|
11.1 Percentage of participants
|
5.0 Percentage of participants
|
4.7 Percentage of participants
|
4.9 Percentage of participants
|
|
Angina Pectoris Classification
Stable Angina - Class I
|
17.9 Percentage of participants
|
1.2 Percentage of participants
|
3.7 Percentage of participants
|
6.2 Percentage of participants
|
2.0 Percentage of participants
|
2.4 Percentage of participants
|
2.8 Percentage of participants
|
|
Angina Pectoris Classification
Stable Angina - Class II
|
23.4 Percentage of participants
|
0.6 Percentage of participants
|
0.9 Percentage of participants
|
2.9 Percentage of participants
|
1.7 Percentage of participants
|
1.0 Percentage of participants
|
1.4 Percentage of participants
|
|
Angina Pectoris Classification
Stable Angina - Class III
|
17.6 Percentage of participants
|
0.6 Percentage of participants
|
0.6 Percentage of participants
|
1.3 Percentage of participants
|
1.3 Percentage of participants
|
1.0 Percentage of participants
|
0.4 Percentage of participants
|
|
Angina Pectoris Classification
Stable Angina - Class IV
|
2.7 Percentage of participants
|
0.0 Percentage of participants
|
0.6 Percentage of participants
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.4 Percentage of participants
|
|
Angina Pectoris Classification
Total Unstable Angina
|
12.5 Percentage of participants
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
Adverse Events
Pro-Kinetic Energy Stent
Serious events: 202 serious events
Other events: 118 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Pro-Kinetic Energy Stent
n=329 participants at risk
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|
|
Cardiac disorders
Atrial arrhythmia
|
3.6%
12/329 • Number of events 13 • 36 Months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Cardiac disorders
Unspecified arrhythmia
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Cardiac disorders
Bradycardia
|
1.2%
4/329 • Number of events 4 • 36 Months
|
|
Cardiac disorders
Cardiac decompensation
|
0.91%
3/329 • Number of events 6 • 36 Months
|
|
Cardiac disorders
Cardiogenic shock
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Cardiac disorders
Chest pain
|
10.0%
33/329 • Number of events 42 • 36 Months
|
|
Cardiac disorders
Congestive/worsening heart failure
|
4.6%
15/329 • Number of events 16 • 36 Months
|
|
Cardiac disorders
Diaphragmatic stimulation
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Dyspnea
|
2.7%
9/329 • Number of events 9 • 36 Months
|
|
Cardiac disorders
Edema
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Cardiac disorders
Elective pacemaker/ICD implantation
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Cardiac disorders
Elevated cardiac enzymes
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Cardiac disorders
Heart block
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Hypertension
|
1.8%
6/329 • Number of events 6 • 36 Months
|
|
Cardiac disorders
Hypertensive urgency
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Cardiac disorders
Ischemic cardiomyopathy
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Left ventricle penetration observed on LV gram
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Myocardial infarction
|
5.2%
17/329 • Number of events 20 • 36 Months
|
|
Cardiac disorders
Palpitations
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Cardiac disorders
Peri-procedural myocardial infarction
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Planned PCI procedure
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Cardiac disorders
Planned routine angiography
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Cardiac disorders
Pleural effusion
|
1.2%
4/329 • Number of events 4 • 36 Months
|
|
Cardiac disorders
Stenosis/occlusion of target lesion within non-study stented segment
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Stenosis/restenosis of non-target lesion in target vessel
|
4.3%
14/329 • Number of events 19 • 36 Months
|
|
Cardiac disorders
Stenosis/restenosis of non-target vessel
|
8.2%
27/329 • Number of events 36 • 36 Months
|
|
Cardiac disorders
Syncope
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Cardiac disorders
Valvular heart disease
|
1.5%
5/329 • Number of events 6 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis/cheilitis
|
0.30%
1/329 • Number of events 2 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Cicatricial changes to the left lower eyelid
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Non-healing wound
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Ulcer
|
0.91%
3/329 • Number of events 5 • 36 Months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Metabolism and nutrition disorders
Hypokalemia and/or hypomagnaesemia
|
0.91%
3/329 • Number of events 4 • 36 Months
|
|
Endocrine disorders
Hypothyroidism
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Endocrine disorders
Left adrenal mass
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Endocrine disorders
Thyroid nodule
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Endocrine disorders
Worsening diabetes
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
Abdominal bloating
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Gastrointestinal disorders
Acute gangrenous cholecystitis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Anastomotic disruption
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Atypical chest pain
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Candida esophagitis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Cholecystitis
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
Colitis
|
0.61%
2/329 • Number of events 4 • 36 Months
|
|
Gastrointestinal disorders
Constipation
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Gastrointestinal disorders
Diverticulosis
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
Elective bariatric surgery
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Epigastric pain
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
2.7%
9/329 • Number of events 10 • 36 Months
|
|
Gastrointestinal disorders
Gastritis
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Gastrointestinal disorders
Heartburn
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Intestinal ilius
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.91%
3/329 • Number of events 4 • 36 Months
|
|
Gastrointestinal disorders
Septic shock
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Tubulovillous adenoma of ascending colon
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
7/329 • Number of events 8 • 36 Months
|
|
Renal and urinary disorders
Acute onset chronic renal injury
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Acute renal failure
|
2.1%
7/329 • Number of events 7 • 36 Months
|
|
Renal and urinary disorders
Contrast induced increased creatinine/acute renal insufficiency
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Hematuria
|
1.2%
4/329 • Number of events 4 • 36 Months
|
|
Renal and urinary disorders
Polyuria
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Prostatic bleeding
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Renal stone
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Urinary retention
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
10/329 • Number of events 12 • 36 Months
|
|
Blood and lymphatic system disorders
Bleeding requiring treatment
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Blood and lymphatic system disorders
Coumadin toxicity
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Blood and lymphatic system disorders
Hematoma - TAVI access site bleed
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.61%
2/329 • Number of events 3 • 36 Months
|
|
Blood and lymphatic system disorders
Supratherapeutic INR
|
0.91%
3/329 • Number of events 4 • 36 Months
|
|
Infections and infestations
Bronchitis
|
2.1%
7/329 • Number of events 7 • 36 Months
|
|
Infections and infestations
Cellulitis
|
1.2%
4/329 • Number of events 4 • 36 Months
|
|
Infections and infestations
Fever
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Infections and infestations
HSV pneumonitis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Infections and infestations
Leukocytosis
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Infections and infestations
MRSA
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Infections and infestations
Oral thrush
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Infections and infestations
Osteomyelitis
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Infections and infestations
Pneumonia
|
3.6%
12/329 • Number of events 17 • 36 Months
|
|
Infections and infestations
Sepsis
|
0.91%
3/329 • Number of events 4 • 36 Months
|
|
Infections and infestations
Surgical site dehiscence
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Infections and infestations
Urinary tract infection
|
3.3%
11/329 • Number of events 11 • 36 Months
|
|
Infections and infestations
Wound
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Calcar fracture
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Genu varus deformity of right knee
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal injury/fall
|
3.3%
11/329 • Number of events 11 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
5/329 • Number of events 5 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Vertebral fracture
|
0.61%
2/329 • Number of events 3 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Worsening/degenerative osteoarthritis
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Nervous system disorders
Dizziness
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Nervous system disorders
Encephalopathy
|
1.8%
6/329 • Number of events 6 • 36 Months
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Nervous system disorders
Neuropathic pain
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Nervous system disorders
Stroke
|
0.91%
3/329 • Number of events 4 • 36 Months
|
|
Nervous system disorders
Transient ischemic attack
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Eye disorders
Cataracts
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Eye disorders
Eye irritation
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Eye disorders
Herpes opthalmicus
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Eye disorders
Low pupillary dilation
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Eye disorders
Strabismus
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Psychiatric disorders
Depression with suicidal ideations
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Psychiatric disorders
Major depression, chronic, recurrent with psychotic features
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
3.0%
10/329 • Number of events 13 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
End-stage lung disease
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Lung rheumatism
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
5/329 • Number of events 5 • 36 Months
|
|
Cardiac disorders
Atypical chest pain
|
1.2%
4/329 • Number of events 5 • 36 Months
|
|
Gastrointestinal disorders
Dehydration
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Extracardiac pain
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Fever
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Headache
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Steroid toxicogenic reaction
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Vasovagal episode
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Abdominal aortic aneurysm
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Vascular disorders
Carotid artery disease
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Deep vein thrombosis
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Vascular disorders
Femoral artery thrombosis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Iliac artery stenosis / occlusion
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Vascular disorders
Peripheral ischemia
|
2.7%
9/329 • Number of events 13 • 36 Months
|
|
Vascular disorders
Pseudoaneurysm
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Systemic emboli - spleen
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Vessel dissection or perforation
|
1.5%
5/329 • Number of events 5 • 36 Months
|
|
Vascular disorders
Worsening of peripheral artery disease
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Worsening ulceration
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Stenosis or occlusion of target lesion within stent segment
|
8.2%
27/329 • Number of events 33 • 36 Months
|
|
Vascular disorders
Stent thrombosis
|
1.5%
5/329 • Number of events 5 • 36 Months
|
|
Vascular disorders
Stent thrombosis, ARC assessment
|
2.7%
9/329 • Number of events 9 • 36 Months
|
|
Vascular disorders
Stent underexpansion
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Vessel dissection or perforation during stenting procedure
|
2.4%
8/329 • Number of events 8 • 36 Months
|
|
Surgical and medical procedures
Elevated troponin
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Surgical and medical procedures
Hematoma
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Abdominal mass
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma in situ
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapsed myeloma
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.91%
3/329 • Number of events 5 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cecum and liver cancer
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenocarcinoma
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Angina
|
0.30%
1/329 • Number of events 2 • 36 Months
|
|
Cardiac disorders
Arrhythmia, Ventricular Extrasystole
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Ascites
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Fatigue
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Cardiac disorders
Hypotension
|
0.91%
3/329 • Number of events 4 • 36 Months
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Non-specific ST-T changes
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Pericardial effusion
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Premature ventricular contractions
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Pulmonary hypertension
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Stenosis - location unknown
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Vasospasm
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Worsening Coronary Artery Disease
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Endocrine disorders
Adrenal nodule
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Endocrine disorders
Gout
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Endocrine disorders
Hypoglycemia
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Abdominal incisional hernia
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Diarrhea
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Gall bladder stone
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.30%
1/329 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.91%
3/329 • Number of events 3 • 36 Months
|
|
Gastrointestinal disorders
Hiatal hernie
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Percutaneous endoscopic gastrostomy complication
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Unbilica hernia
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Benign prostatic hyperplasia
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Obstructive prostatism
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Blood and lymphatic system disorders
Hypovolemia
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Blood and lymphatic system disorders
Subtherapeutic INR
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Knee arthooplasty
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Infections and infestations
Sinusitis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Infections and infestations
Pancreas infection
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Left knee degenerative joint disease
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Right hand weakness
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Ulnar fracture
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Nervous system disorders
Seisure
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Nervous system disorders
spinal stenosis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Nervous system disorders
Syndope
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Psychiatric disorders
Anxiety
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Acute renal injury
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Renal and urinary disorders
Renal insufficiency
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Renal obstruction
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Fibrotic Lung Disease
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Left pneumothorax
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Hematoma
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Vascular disorders
Peripheral vascular disease
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Post-surgical bleeding
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Vascular disorders
Saphenous vein insufficiency
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Immune system disorders
Allergic reaction to contrast media
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Immune system disorders
Allergic reaction with angioedema
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Ear and labyrinth disorders
Decreased hearing
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Dyspnea
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Metabolic acidosis
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Non-cardiac chest pain
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
General disorders
Syncope
|
0.61%
2/329 • Number of events 2 • 36 Months
|
|
Vascular disorders
Possible PCI
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Pacemaker manfunction
|
0.30%
1/329 • Number of events 1 • 36 Months
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.30%
1/329 • Number of events 1 • 36 Months
|
Other adverse events
| Measure |
Pro-Kinetic Energy Stent
n=329 participants at risk
PRO-Kinetic Energy Stent: Coronary artery stent implant
|
|---|---|
|
Cardiac disorders
Chest pain
|
17.9%
59/329 • Number of events 77 • 36 Months
|
|
Cardiac disorders
Dizziness
|
9.4%
31/329 • Number of events 35 • 36 Months
|
|
Cardiac disorders
Dyspnea
|
13.4%
44/329 • Number of events 55 • 36 Months
|
|
Cardiac disorders
Fatigue
|
6.7%
22/329 • Number of events 30 • 36 Months
|
|
Cardiac disorders
Hypertension
|
9.1%
30/329 • Number of events 35 • 36 Months
|
|
Cardiac disorders
Muskuloskeletal injury/fall
|
5.5%
18/329 • Number of events 29 • 36 Months
|
|
General disorders
Headache
|
7.6%
25/329 • Number of events 30 • 36 Months
|
|
Cardiac disorders
Atrial Arrhyrhmia
|
5.2%
17/329 • Number of events 22 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.5%
18/329 • Number of events 19 • 36 Months
|
Additional Information
Amy Culley, Director of Vascular Intervention
BIOTRONIK
Phone: 503-451-8034
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place