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BIOHELIX-I Bare Metal Stent Study (BIOHELIX-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01612767
Recruitment Status : Completed
First Posted : June 6, 2012
Results First Posted : May 30, 2017
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Arteries Disease
Intervention Device: PRO-Kinetic Energy Stent
Enrollment 329
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pro-Kinetic Energy Stent
Hide Arm/Group Description PRO-Kinetic Energy Stent: Coronary artery stent implant
Period Title: Overall Study
Started 329
Completed 287
Not Completed 42
Arm/Group Title Pro-Kinetic Energy Stent
Hide Arm/Group Description PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Baseline Participants 329
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 329 participants
69.0  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants
Female
103
  31.3%
Male
226
  68.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants
Hispanic or Latino
23
   7.0%
Not Hispanic or Latino
306
  93.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants
American Indian or Alaska Native
1
   0.3%
Asian
6
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
17
   5.2%
White
305
  92.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants
United States 215
Germany 88
Netherlands 17
Latvia 8
Colombia 1
Medical History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants
Diabetes 94
Hypertension 276
Hyperlipidemia 240
Current smoker 60
Smoked within last 5 years 31
Never smoked or not within last 5 years 238
History of myocardial infarction (MI) 67
Prior coronary artery bypass graft (CABG) 27
Prior percutaneous coronary revascularization 100
Renal insufficiency 8
Concomitant Medications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants
Dual Antiplatelet Therapy (DAPT) 96
Aspirin 260
Antiplatelet - Clopidogrel 79
Antiplatelet - Prasugrel 9
Antiplatelet - Ticagrelor 15
Antiotensin-converting-enzyme (ACE) inhibitor 135
Angiotensin II receptor blocker 78
Beta blocker 203
Statins 213
Insulin 37
Anti-coagulant 32
Lesion Location  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants
Left Anterior Descending (LAD) 122
Circumflex 82
Right 125
Lesion Length  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 329 participants
13.7  (6.0)
Vessel Diameter   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 329 participants
Pre-deployment target vessel MLD 0.9  (0.4)
Pre-deployment target vessel reference diameter 2.9  (0.5)
Post-deployment target vessel MLD 3.1  (0.5)
[1]
Measure Description: MLD = minimal luminal diameter
Lesion Calcification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants
None 245
Moderate 58
Severe 26
Thrombolysis in Myocardial Infarction (TIMI) Flow   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants
0 1
1 6
2 24
3 298
[1]
Measure Description: TIMI Flow is a system developed during Thrombolysis in Myocardial Infarction (TIMI) trials for grading severity of stenosis and extent of blood flow through coronary arteries; TIMI grade 0 = no perfusion; grade 1 = penetration with minimal perfusion; grade 2 = partial perfusion; grade 3 = complete perfusion. Grade 0 represents no flow beyond an occlusion, while grade 3 represents normal flow.
1.Primary Outcome
Title Target Vessel Failure Rate
Hide Description 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.
Time Frame 9 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pro-Kinetic Energy Stent
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 320
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Overall Target Vessel Failure Rate
9.06
(6.15 to 12.76)
Cardiac death
0.95
(0.20 to 2.74)
Myocardial infarction
1.58
(0.52 to 3.65)
Ischemia-driven target vessel revascularization
7.26
(4.65 to 10.69)
2.Secondary Outcome
Title Target Vessel Failure Rate
Hide Description 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.
Time Frame 1, 12, 24 and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title PRO-Kinetic Energy Stent
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 327
Measure Type: Number
Unit of Measure: Percentage of participants
1 Month Number Analyzed 327 participants
1.22
12 Months Number Analyzed 316 participants
10.76
24 Months Number Analyzed 309 participants
13.26
36 Months Number Analyzed 301 participants
17.61
3.Secondary Outcome
Title Target Vessel Failure Rate - Contribution of Individual Event Types
Hide Description Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.
Time Frame 1, 12, 24 and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title PRO-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 12 Months PRO-Kinetic Energy Stent - 24 Months PRO-Kinetic Energy Stent - 36 Months
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 327 316 309 301
Measure Type: Number
Unit of Measure: Percentage of participants
Cardiac death 0.00 0.96 2.30 4.07
Myocardial infarction 0.61 1.61 2.00 3.50
Ischemia-driven target vessel revascularization 0.61 8.97 10.23 12.46
4.Secondary Outcome
Title Overall Target Vessel Revascularization Rate
Hide Description 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.
Time Frame 1, 9, 12, 24 and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title Pro-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 9 Month PRO-Kinetic Energy Stent - 12 Month PRO-Kinetic Energy Stent - 24 Month PRO-Kinetic Energy Stent - 36 Month
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 327 318 312 303 289
Measure Type: Number
Unit of Measure: Percentage of participants
0.61 7.86 9.62 11.55 13.84
5.Secondary Outcome
Title Overall Target Lesion Failure Rate
Hide Description 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.
Time Frame 1, 9, 12, 24 and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title Pro-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 9 Month PRO-Kinetic Energy Stent - 12 Month PRO-Kinetic Energy Stent - 24 Month PRO-Kinetic Energy Stent - 36 Month
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 327 321 315 308 300
Measure Type: Number
Unit of Measure: Percentage of participants
1.22 8.41 9.84 11.68 15.33
6.Secondary Outcome
Title Target Lesion Failure Rate - Contribution of Individual Event Types
Hide Description 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.
Time Frame 1, 9, 12, 24, and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title Pro-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 9 Month Pro-Kinetic Energy Stent - 12 Month Pro-Kinetic Energy Stent - 24 Month Pro-Kinetic Energy Stent - 36 Month
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 327 321 315 308 300
Measure Type: Number
Unit of Measure: Percentage of participants
Cardiac death 0.00 0.95 0.96 2.30 4.07
Myocardial infarction 0.61 1.58 1.61 2.00 3.50
Ischemia-driven target vessel revascularization 0.61 6.60 8.04 8.61 10.07
7.Secondary Outcome
Title Overall Target Lesion Revascularization Rate
Hide Description 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.
Time Frame 1, 9, 12, 24 and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title Pro-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 9 Month PRO-Kinetic Energy Stent - 12 Month PRO-Kinetic Energy Stent -24 Month PRO-Kinetic Energy Stent - 36 Month
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 327 318 312 303 289
Measure Type: Number
Unit of Measure: Percentage of participants
0.61 7.23 8.65 9.24 10.37
8.Secondary Outcome
Title Composite of All-cause Mortality and All-cause MI
Hide Description Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.
Time Frame 1, 9, 12, 24, and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title Pro-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 9 Month PRO-Kinetic Energy Stent - 12 Month PRO-Kinetic Energy Stent - 24 Month PRO-Kinetic Energy Stent - 36 Month
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 326 321 317 314 311
Measure Type: Number
Unit of Measure: Percentage of participants
0.61 3.12 3.79 7.32 11.25
9.Secondary Outcome
Title All-cause Mortality and All-cause MI - Contribution of Individual Rates
Hide Description Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.
Time Frame 1, 9, 12, 24, and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title Pro-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 9 Month PRO-Kinetic Energy Stent - 12 Month PRO-Kinetic Energy Stent - 24 Month PRO-Kinetic Energy Stent - 36 Month
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 326 321 317 314 311
Measure Type: Number
Unit of Measure: Percentage of participants
All-cause mortality 0.00 1.87 2.52 5.73 8.68
Cardiac mortality 0.00 0.93 0.95 2.23 3.86
Non-cardiac mortality 0.00 0.93 1.58 3.50 4.82
All-cause MI 0.61 1.56 1.58 1.91 3.22
10.Secondary Outcome
Title Stent Thrombosis Rate
Hide Description 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.
Time Frame 1, 9, 12, 24 and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title Pro-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 9 Month PRO-Kinetic Energy Stent - 12 Month PRO-Kinetic Energy Stent - 24 Month PRO-Kinetic Energy Stent - 36 Month
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 327 319 313 305 293
Measure Type: Number
Unit of Measure: Percentage of participants
Definite stent thrombosis 0.3 0.9 1.0 1.0 1.4
Probable stent thrombosis 0.0 0.3 0.3 0.3 0.3
Total definite / probable stent thrombosis 0.3 1.3 1.3 1.3 1.7
Possible stent thrombosis 0.0 0.9 1.0 1.6 2.7
11.Secondary Outcome
Title Index Procedure Success
Hide Description Evaluate 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.
Time Frame Index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pro-Kinetic Energy Stent
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 329
Measure Type: Number
Unit of Measure: Percentage of participants
98.8
12.Secondary Outcome
Title Device Success During the Index Procedure
Hide Description Evaluate 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.
Time Frame Index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pro-Kinetic Energy Stent
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 329
Measure Type: Number
Unit of Measure: Percentage of participants
99.4
13.Secondary Outcome
Title Lesion Success During the Index Procedure
Hide Description Evaluate 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.
Time Frame Index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pro-Kinetic Energy Stent
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 329
Measure Type: Number
Unit of Measure: Percentage of participants
99.4
14.Secondary Outcome
Title Angina Pectoris Classification
Hide Description

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

Time Frame Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
Arm/Group Title Pro-Kinetic Energy Stent - Baseline PRO-Kinetic Energy Stent - Discharge PRO-Kinetic Energy Stent - 1 Month PRO-Kinetic Energy Stent - 9 Month PRO-Kinetic Energy Stent - 12 Month PRO-Kinetic Energy Stent - 24 Month PRO-Kinetic Energy Stent - 36 Month
Hide Arm/Group Description:
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Number of Participants Analyzed 329 329 326 307 303 296 283
Measure Type: Number
Unit of Measure: Percentage of participants
No Angina 25.8 97.3 93.9 88.9 94.7 95.3 94.3
Total Stable Angina 61.7 2.4 5.8 11.1 5.0 4.7 4.9
Stable Angina - Class I 17.9 1.2 3.7 6.2 2.0 2.4 2.8
Stable Angina - Class II 23.4 0.6 0.9 2.9 1.7 1.0 1.4
Stable Angina - Class III 17.6 0.6 0.6 1.3 1.3 1.0 0.4
Stable Angina - Class IV 2.7 0.0 0.6 0.7 0.0 0.3 0.4
Total Unstable Angina 12.5 0.3 0.3 0.0 0.3 0.0 0.7
Unstable Angine Class IA 1.5 0.0 0.0 0.0 0.0 0.0 0.0
Unstable Angine Class IB 1.8 0.0 0.0 0.0 0.0 0.0 0.0
Unstable Angine Class IC 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Unstable Angine Class IIA 2.7 0.3 0.0 0.0 0.0 0.0 0.0
Unstable Angine Class IIB 2.1 0.0 0.0 0.0 0.0 0.0 0.7
Unstable Angine Class IIC 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Unstable Angine Class IIIA 1.2 0.0 0.0 0.0 0.3 0.0 0.0
Unstable Angine Class IIIB 3.0 0.0 0.3 0.0 0.0 0.0 0.0
Unstable Angine Class IIIC 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Time Frame 36 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pro-Kinetic Energy Stent
Hide Arm/Group Description PRO-Kinetic Energy Stent: Coronary artery stent implant
All-Cause Mortality
Pro-Kinetic Energy Stent
Affected / at Risk (%)
Total   27/311 (8.68%)    
Hide Serious Adverse Events
Pro-Kinetic Energy Stent
Affected / at Risk (%) # Events
Total   202/329 (61.40%)    
Blood and lymphatic system disorders   
Anemia   10/329 (3.04%)  12
Bleeding requiring treatment   2/329 (0.61%)  2
Coagulopathy   1/329 (0.30%)  1
Coumadin toxicity   1/329 (0.30%)  1
Hematoma - TAVI access site bleed   1/329 (0.30%)  1
Pancytopenia   2/329 (0.61%)  3
Supratherapeutic INR   3/329 (0.91%)  4
Hypovolemia   1/329 (0.30%)  1
Subtherapeutic INR   1/329 (0.30%)  1
Lymphadenopathy   1/329 (0.30%)  1
Cardiac disorders   
Atrial arrhythmia   12/329 (3.65%)  13
Ventricular arrhythmia   3/329 (0.91%)  3
Unspecified arrhythmia   3/329 (0.91%)  3
Bradycardia   4/329 (1.22%)  4
Cardiac decompensation   3/329 (0.91%)  6
Cardiogenic shock   1/329 (0.30%)  1
Cardiopulmonary arrest   3/329 (0.91%)  3
Chest pain   33/329 (10.03%)  42
Congestive/worsening heart failure   15/329 (4.56%)  16
Diaphragmatic stimulation   1/329 (0.30%)  1
Dyspnea   9/329 (2.74%)  9
Edema   3/329 (0.91%)  3
Elective pacemaker/ICD implantation   3/329 (0.91%)  3
Elevated cardiac enzymes   2/329 (0.61%)  2
Heart block   1/329 (0.30%)  1
Hypertension   6/329 (1.82%)  6
Hypertensive urgency   2/329 (0.61%)  2
Ischemic cardiomyopathy   1/329 (0.30%)  1
Left ventricle penetration observed on LV gram   1/329 (0.30%)  1
Myocardial infarction   17/329 (5.17%)  20
Palpitations   3/329 (0.91%)  3
Peri-procedural myocardial infarction   1/329 (0.30%)  1
Planned PCI procedure   2/329 (0.61%)  2
Planned routine angiography   2/329 (0.61%)  2
Pleural effusion   4/329 (1.22%)  4
Stenosis/occlusion of target lesion within non-study stented segment   1/329 (0.30%)  1
Stenosis/restenosis of non-target lesion in target vessel   14/329 (4.26%)  19
Stenosis/restenosis of non-target vessel   27/329 (8.21%)  36
Syncope   3/329 (0.91%)  3
Valvular heart disease   5/329 (1.52%)  6
Atypical chest pain   4/329 (1.22%)  5
Angina   1/329 (0.30%)  2
Arrhythmia, Ventricular Extrasystole   1/329 (0.30%)  1
Ascites   1/329 (0.30%)  1
Fatigue   3/329 (0.91%)  3
Hypotension   3/329 (0.91%)  4
Hypertrophic cardiomyopathy   1/329 (0.30%)  1
Non-specific ST-T changes   1/329 (0.30%)  1
Pericardial effusion   1/329 (0.30%)  1
Premature ventricular contractions   1/329 (0.30%)  1
Pulmonary hypertension   1/329 (0.30%)  1
Stenosis - location unknown   1/329 (0.30%)  1
Vasospasm   1/329 (0.30%)  1
Worsening Coronary Artery Disease   3/329 (0.91%)  3
Pacemaker manfunction   1/329 (0.30%)  1
Ear and labyrinth disorders   
Decreased hearing   1/329 (0.30%)  1
Endocrine disorders   
Hypothyroidism   1/329 (0.30%)  1
Left adrenal mass   1/329 (0.30%)  1
Thyroid nodule   1/329 (0.30%)  1
Worsening diabetes   2/329 (0.61%)  2
Adrenal nodule   1/329 (0.30%)  1
Gout   1/329 (0.30%)  1
Hypoglycemia   1/329 (0.30%)  1
Eye disorders   
Cataracts   2/329 (0.61%)  2
Eye irritation   1/329 (0.30%)  1
Herpes opthalmicus   1/329 (0.30%)  1
Low pupillary dilation   1/329 (0.30%)  1
Strabismus   1/329 (0.30%)  1
Gastrointestinal disorders   
Abdominal bloating   1/329 (0.30%)  1
Abdominal pain   3/329 (0.91%)  3
Acute gangrenous cholecystitis   1/329 (0.30%)  1
Anastomotic disruption   1/329 (0.30%)  1
Atypical chest pain   1/329 (0.30%)  1
Candida esophagitis   1/329 (0.30%)  1
Cholecystitis   2/329 (0.61%)  2
Colitis   2/329 (0.61%)  4
Constipation   3/329 (0.91%)  3
Diverticulosis   2/329 (0.61%)  2
Elective bariatric surgery   1/329 (0.30%)  1
Epigastric pain   1/329 (0.30%)  1
Epiploic appendagitis   1/329 (0.30%)  1
Gastrointestinal bleed   9/329 (2.74%)  10
Gastritis   3/329 (0.91%)  3
Heartburn   1/329 (0.30%)  1
Intestinal ilius   1/329 (0.30%)  1
Intestinal obstruction   1/329 (0.30%)  1
Nausea and/or vomiting   3/329 (0.91%)  3
Pancreatitis   3/329 (0.91%)  4
Septic shock   1/329 (0.30%)  1
Small bowel obstruction   1/329 (0.30%)  1
Tubulovillous adenoma of ascending colon   1/329 (0.30%)  1
Dehydration   2/329 (0.61%)  2
Dysphagia   1/329 (0.30%)  1
Abdominal mass   1/329 (0.30%)  1
Abdominal distension   1/329 (0.30%)  1
Abdominal incisional hernia   1/329 (0.30%)  1
Diarrhea   1/329 (0.30%)  1
Gall bladder stone   1/329 (0.30%)  1
Gastroenteritis   1/329 (0.30%)  2
Gastroesophageal reflux disease   3/329 (0.91%)  3
Hiatal hernie   1/329 (0.30%)  1
Percutaneous endoscopic gastrostomy complication   1/329 (0.30%)  1
Rectal bleeding   1/329 (0.30%)  1
Unbilica hernia   1/329 (0.30%)  1
General disorders   
Extracardiac pain   1/329 (0.30%)  1
Fever   1/329 (0.30%)  1
Headache   1/329 (0.30%)  1
Steroid toxicogenic reaction   1/329 (0.30%)  1
Vasovagal episode   1/329 (0.30%)  1
Dyspnea   2/329 (0.61%)  2
Metabolic acidosis   1/329 (0.30%)  1
Non-cardiac chest pain   1/329 (0.30%)  1
Syncope   2/329 (0.61%)  2
Immune system disorders   
Allergic reaction to contrast media   1/329 (0.30%)  1
Allergic reaction with angioedema   1/329 (0.30%)  1
Infections and infestations   
Bronchitis   7/329 (2.13%)  7
Cellulitis   4/329 (1.22%)  4
Fever   1/329 (0.30%)  1
Gastrointestinal viral infection   1/329 (0.30%)  1
HSV pneumonitis   1/329 (0.30%)  1
Leukocytosis   3/329 (0.91%)  3
MRSA   2/329 (0.61%)  2
Oral thrush   1/329 (0.30%)  1
Osteomyelitis   2/329 (0.61%)  2
Pneumonia   12/329 (3.65%)  17
Sepsis   3/329 (0.91%)  4
Surgical site dehiscence   1/329 (0.30%)  1
Urinary tract infection   11/329 (3.34%)  11
Wound   1/329 (0.30%)  1
Sinusitis   1/329 (0.30%)  1
Pancreas infection   1/329 (0.30%)  1
Metabolism and nutrition disorders   
Hypercalcemia   1/329 (0.30%)  1
Hyperkalemia   2/329 (0.61%)  2
Hypernatremia   2/329 (0.61%)  2
Hypokalemia and/or hypomagnaesemia   3/329 (0.91%)  4
hyponatremia   1/329 (0.30%)  1
Musculoskeletal and connective tissue disorders   
Back pain   2/329 (0.61%)  2
Calcar fracture   1/329 (0.30%)  1
Carpal tunnel syndrome   1/329 (0.30%)  1
Chest pain   1/329 (0.30%)  1
Genu varus deformity of right knee   1/329 (0.30%)  1
Muscle weakness   1/329 (0.30%)  1
Musculoskeletal injury/fall   11/329 (3.34%)  11
Musculoskeletal pain   5/329 (1.52%)  5
Vertebral fracture   2/329 (0.61%)  3
Worsening/degenerative osteoarthritis   3/329 (0.91%)  3
Knee arthooplasty   1/329 (0.30%)  1
Knee pain   1/329 (0.30%)  1
Left knee degenerative joint disease   1/329 (0.30%)  1
Osteoarthritis   1/329 (0.30%)  1
Right hand weakness   1/329 (0.30%)  1
Ulnar fracture   1/329 (0.30%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
B-cell lymphoma   1/329 (0.30%)  1
Basal cell carcinoma   2/329 (0.61%)  2
Bladder cancer   1/329 (0.30%)  1
Brain cancer   2/329 (0.61%)  2
Hepatocellular carcinoma   1/329 (0.30%)  1
Lung cancer   3/329 (0.91%)  3
Melanoma in situ   1/329 (0.30%)  1
Relapsed myeloma   1/329 (0.30%)  1
Squamous cell carcinoma   3/329 (0.91%)  5
Bronchial carcinoma   1/329 (0.30%)  1
Cecum and liver cancer   1/329 (0.30%)  1
Colon adenocarcinoma   1/329 (0.30%)  1
Nervous system disorders   
Dizziness   3/329 (0.91%)  3
Encephalopathy   6/329 (1.82%)  6
Lumbar radiculopathy   1/329 (0.30%)  1
Neuropathic pain   1/329 (0.30%)  1
Stroke   3/329 (0.91%)  4
Transient ischemic attack   3/329 (0.91%)  3
Seisure   1/329 (0.30%)  1
spinal stenosis   1/329 (0.30%)  1
Syndope   2/329 (0.61%)  2
Psychiatric disorders   
Depression with suicidal ideations   1/329 (0.30%)  1
Major depression, chronic, recurrent with psychotic features   1/329 (0.30%)  1
Anxiety   1/329 (0.30%)  1
Renal and urinary disorders   
Acute kidney injury   7/329 (2.13%)  8
Acute onset chronic renal injury   1/329 (0.30%)  1
Acute renal failure   7/329 (2.13%)  7
Contrast induced increased creatinine/acute renal insufficiency   1/329 (0.30%)  1
Hematuria   4/329 (1.22%)  4
Polyuria   1/329 (0.30%)  1
Prostatic bleeding   1/329 (0.30%)  1
Renal stone   1/329 (0.30%)  1
Urinary retention   2/329 (0.61%)  2
Benign prostatic hyperplasia   1/329 (0.30%)  1
Obstructive prostatism   1/329 (0.30%)  1
Acute renal injury   2/329 (0.61%)  2
Renal insufficiency   1/329 (0.30%)  1
Renal obstruction   1/329 (0.30%)  1
Respiratory, thoracic and mediastinal disorders   
COPD exacerbation   10/329 (3.04%)  13
Cough   3/329 (0.91%)  3
Dyspnea   1/329 (0.30%)  1
End-stage lung disease   1/329 (0.30%)  1
Hypoxia   2/329 (0.61%)  2
Lung rheumatism   1/329 (0.30%)  1
Pulmonary embolism   3/329 (0.91%)  3
Respiratory arrest   1/329 (0.30%)  1
Respiratory distress   2/329 (0.61%)  2
Respiratory failure   5/329 (1.52%)  5
Acute respiratory failure   1/329 (0.30%)  1
Bronchitis   1/329 (0.30%)  1
Chronic Fibrotic Lung Disease   1/329 (0.30%)  1
Left pneumothorax   1/329 (0.30%)  1
Nasal obstruction   1/329 (0.30%)  1
Pleural effusion   1/329 (0.30%)  1
Pulmonary edema   1/329 (0.30%)  1
Skin and subcutaneous tissue disorders   
Actinic keratosis/cheilitis   1/329 (0.30%)  2
Cicatricial changes to the left lower eyelid   1/329 (0.30%)  1
Contact dermatitis   1/329 (0.30%)  1
Non-healing wound   1/329 (0.30%)  1
Ulcer   3/329 (0.91%)  5
Surgical and medical procedures   
Elevated troponin   1/329 (0.30%)  1
Hematoma   1/329 (0.30%)  1
Vascular disorders   
Abdominal aortic aneurysm   3/329 (0.91%)  3
Carotid artery disease   1/329 (0.30%)  1
Deep vein thrombosis   3/329 (0.91%)  3
Femoral artery thrombosis   1/329 (0.30%)  1
Iliac artery stenosis / occlusion   2/329 (0.61%)  2
Peripheral ischemia   9/329 (2.74%)  13
Pseudoaneurysm   1/329 (0.30%)  1
Systemic emboli - spleen   1/329 (0.30%)  1
Vessel dissection or perforation   5/329 (1.52%)  5
Worsening of peripheral artery disease   1/329 (0.30%)  1
Worsening ulceration   1/329 (0.30%)  1
Stenosis or occlusion of target lesion within stent segment   27/329 (8.21%)  33
Stent thrombosis   5/329 (1.52%)  5
Stent thrombosis, ARC assessment   9/329 (2.74%)  9
Stent underexpansion   1/329 (0.30%)  1
Vessel dissection or perforation during stenting procedure   8/329 (2.43%)  8
Hematoma   2/329 (0.61%)  2
Peripheral vascular disease   1/329 (0.30%)  1
Post-surgical bleeding   1/329 (0.30%)  1
Saphenous vein insufficiency   1/329 (0.30%)  1
Possible PCI   1/329 (0.30%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pro-Kinetic Energy Stent
Affected / at Risk (%) # Events
Total   118/329 (35.87%)    
Cardiac disorders   
Chest pain   59/329 (17.93%)  77
Dizziness   31/329 (9.42%)  35
Dyspnea   44/329 (13.37%)  55
Fatigue   22/329 (6.69%)  30
Hypertension   30/329 (9.12%)  35
Muskuloskeletal injury/fall   18/329 (5.47%)  29
Atrial Arrhyrhmia   17/329 (5.17%)  22
General disorders   
Headache   25/329 (7.60%)  30
Musculoskeletal and connective tissue disorders   
Back Pain   18/329 (5.47%)  19
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Amy Culley, Director of Vascular Intervention
Organization: BIOTRONIK
Phone: 503-451-8034
EMail: amy.culley@biotronik.com
Layout table for additonal information
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01612767    
Other Study ID Numbers: G110147
First Submitted: June 4, 2012
First Posted: June 6, 2012
Results First Submitted: December 27, 2016
Results First Posted: May 30, 2017
Last Update Posted: September 28, 2018