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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT01612767
First received: June 4, 2012
Last updated: July 17, 2017
Last verified: July 2017
Results First Received: December 27, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Coronary Arteries Disease
Intervention: Device: PRO-Kinetic Energy Stent

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pro-Kinetic Energy Stent PRO-Kinetic Energy Stent: Coronary artery stent implant

Participant Flow:   Overall Study
    Pro-Kinetic Energy Stent
STARTED   329 
COMPLETED   320 
NOT COMPLETED   9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Pro-Kinetic Energy Stent PRO-Kinetic Energy Stent: Coronary artery stent implant

Baseline Measures
   Pro-Kinetic Energy Stent 
Overall Participants Analyzed 
[Units: Participants]
 329 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.0  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      103  31.3% 
Male      226  68.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      23   7.0% 
Not Hispanic or Latino      306  93.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   215 
Germany   88 
Netherlands   17 
Latvia   8 
Colombia   1 
Medical History 
[Units: Participants]
 
Diabetes   94 
Hypertension   275 
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 
[Units: Participants]
 
Dual Antiplatelet Therapy (DAPT)   96 
Aspirin   260 
Antiplatelet - Clopidogrel   79 
Antiplatelet - Prasugrel   9 
Antiplatelet - Ticagrelor   15 
Antiotensin-converting-enzyme (ACE) inhibitor   134 
Angiotensin II receptor blocker   78 
Beta blocker   203 
Statins   213 
Insulin   37 
Anti-coagulant   32 
Lesion Location 
[Units: Participants]
 
Left Anterior Descending (LAD)   122 
Circumflex   82 
Right   125 
Lesion Length 
[Units: Mm]
Mean (Standard Deviation)
 13.7  (6.0) 
Vessel Diameter [1] 
[Units: Mm]
Mean (Standard Deviation)
 
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] MLD = minimal luminal diameter
Lesion Calcification 
[Units: Participants]
 
None   245 
Moderate   58 
Severe   26 
Thrombolysis in Myocardial Infarction (TIMI) Flow [1] 
[Units: Participants]
 
 1 
 6 
 24 
 298 
[1] 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.


  Outcome Measures
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1.  Primary:   Target Vessel Failure Rate   [ Time Frame: 9 months post-index procedure ]

2.  Secondary:   Target Vessel Failure Rate   [ Time Frame: 1, 12, 24 and 36 months post-index procedure ]

3.  Secondary:   Target Vessel Failure Rate - Contribution of Individual Event Types   [ Time Frame: 1, 12, 24 and 36 months post-index procedure ]

4.  Secondary:   Overall Target Vessel Revascularization Rate   [ Time Frame: 1, 9, 12, 24 and 36 months post-index procedure ]

5.  Secondary:   Overall Target Lesion Failure Rate   [ Time Frame: 1, 9, 12, 24 and 36 months post-index procedure ]

6.  Secondary:   Target Lesion Failure Rate - Contribution of Individual Event Types   [ Time Frame: 1, 9, 12, 24, and 36 months post-index procedure ]

7.  Secondary:   Overall Target Lesion Revascularization Rate   [ Time Frame: 1, 9, 12, 24 and 36 months post-index procedure ]

8.  Secondary:   Composite of All-cause Mortality and All-cause MI   [ Time Frame: 1, 9, 12, 24, and 36 months post-index procedure ]

9.  Secondary:   All-cause Mortality and All-cause MI - Contribution of Individual Rates   [ Time Frame: 1, 9, 12, 24, and 36 months post-index procedure ]

10.  Secondary:   Stent Thrombosis Rate   [ Time Frame: 1, 9, 12, 24 and 36 months post-index procedure ]

11.  Secondary:   Index Procedure Success   [ Time Frame: Index procedure ]

12.  Secondary:   Device Success During the Index Procedure   [ Time Frame: Index procedure ]

13.  Secondary:   Lesion Success During the Index Procedure   [ Time Frame: Index procedure ]

14.  Secondary:   Angina Pectoris Classification   [ Time Frame: Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Amy Culley, Director of Vascular Intervention
Organization: BIOTRONIK
phone: 503-451-8034
e-mail: amy.culley@biotronik.com



Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01612767     History of Changes
Other Study ID Numbers: G110147
Study First Received: June 4, 2012
Results First Received: December 27, 2016
Last Updated: July 17, 2017