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Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents (BIOFLEX-I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT01319812
First received: March 18, 2011
Last updated: May 3, 2017
Last verified: May 2017
Results First Received: September 2, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Interventions: Device: Astron Stents
Device: Pulsar Stents

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Astron Stent Group Subjects implanted with an Astron stent.
Pulsar Stent Group Subjects implanted with an Astron Pulsar or Pulsar-18 stent.

Participant Flow:   Overall Study
    Astron Stent Group   Pulsar Stent Group
STARTED   161   302 
COMPLETED   145   280 
NOT COMPLETED   16   22 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
The two arms of the BIOFLEX-I study were distinct with no overlap. Totals present here were automatically generated by the clinicaltrials.gov system. Four participants were enrolled in both the Astron and Pulsar stent groups, as allowed in the study protocol. Therefore any presented totals may not be accurate aggregates of data.

Reporting Groups
  Description
Astron Stent Group Subjects implanted with an Astron stent.
Pulsar Stent Group Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
Total Total of all reporting groups

Baseline Measures
   Astron Stent Group   Pulsar Stent Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 161   302   463 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 63.6  (10.1)   67.3  (10.3)   NA [1] 
[1] Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      56  34.8%      97  32.1%      153  33.0% 
Male      105  65.2%      205  67.9%      310  67.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      18  11.2%      21   7.0%      39   8.4% 
Not Hispanic or Latino      143  88.8%      281  93.0%      424  91.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.6%      0   0.0%      1   0.2% 
Asian      4   2.5%      7   2.3%      11   2.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   2.5%      22   7.3%      26   5.6% 
White      152  94.4%      273  90.4%      425  91.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment [1] 
[Units: Participants]
     
United States   91   187   NA [1] 
Canada   38   29   NA [1] 
Austria   32   34   NA [1] 
Belgium   0   32   NA [1] 
Switzerland   0   6   NA [1] 
Germany   0   14   NA [1] 
[1] Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Medical History [1] 
[Units: Participants]
     
Diabetes   32   123   NA [1] 
Hypertension   117   255   NA [1] 
Hyperlipidemia   125   245   NA [1] 
Current smoker   78   122   NA [1] 
Smoked within last 5 years   36   46   NA [1] 
Never smoked or not within last 5 years   47   134   NA [1] 
Cerebrovascular disease   22   48   NA [1] 
History of congestive heart failure   11   27   NA [1] 
History of ischemic heart disease   69   124   NA [1] 
History of coronary revasularization   54   110   NA [1] 
Renal insufficiency   11   17   NA [1] 
[1] Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Lesion Location 
[Units: Participants]
     
Common iliac   107   0   107 
External iliac   54   0   54 
Ostial SFA   0   2   2 
Proximal SFA   0   38   38 
Mid SFA   0   156   156 
Distal SFA   0   99   99 
Proximal popliteal   0   7   7 
Lesion Calcification [1] 
[Units: Participants]
     
None   47   82   NA [1] 
Moderate   68   91   NA [1] 
Severe   46   129   NA [1] 
[1] Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Lesion Length [1] 
[Units: Mm]
Mean (Standard Deviation)
 35.9  (21.3)   82.0  (46.9)   NA [1] 
[1] Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Vessel Diameter [1] 
[Units: Mm]
Mean (Standard Deviation)
     
Pre-deployment Minimum Lumen Diameter (MLD)   2.1  (1.3)   1.0  (0.9)   NA [1] 
Post-deployment Minimum Lumen Diameter (MLD)   6.0  (1.2)   4.1  (0.7)   NA [1] 
Reference vessel diameter   7.6  (1.5)   5.0  (0.9)   NA [1] 
[1] Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Distal Vessel Runoff [1] 
[Units: Participants]
     
Not Available   35   32   NA [1] 
0 Vessel   9   19   NA [1] 
1 Vessel   32   74   NA [1] 
2 Vessel   48   93   NA [1] 
3 Vessel   37   84   NA [1] 
[1] Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Trans-Atlantic Inter-Society Consensus (TASC II) Type [1] [2] 
[Units: Participants]
     
Type A   99   166   NA [2] 
Type B   56   106   NA [2] 
Type C   6   26   NA [2] 
Type D   0   3   NA [2] 
[1] TASC II grading is from the Trans-Atlantic Inter-Society Consensus. Type A lesions include a single stenosis <10 cm long or a single occlusion <5cm long; type B lesions include multiple lesions <5 cm, a single lesion <15cm, or a single popliteal stenosis; type C lesions include multiple stenosis or occlusions >15 cm with or without calcification, or a chronic total occlusion >20cm involving the popliteal; type D lesions include chronic total occlusions of the popliteal artery and proximal vessels. Generally, Type D lesions are mores severe than Type A lesions.
[2] Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effectiveness Endpoint for the Pulsar Stent: Primary Patency   [ Time Frame: 12 months ]

2.  Primary:   Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events   [ Time Frame: 30 days ]

3.  Primary:   Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)   [ Time Frame: 12 months ]

4.  Secondary:   Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation   [ Time Frame: 30 days ]

5.  Secondary:   Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate   [ Time Frame: 12 months ]

6.  Secondary:   Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate   [ Time Frame: 12 months ]

7.  Secondary:   Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate   [ Time Frame: 12 months ]

8.  Secondary:   Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate   [ Time Frame: 12 months ]

9.  Secondary:   Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency   [ Time Frame: 12 months ]

10.  Secondary:   Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency   [ Time Frame: 12 months ]

11.  Secondary:   Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement   [ Time Frame: 12 months ]

12.  Secondary:   Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test   [ Time Frame: 12 months ]

13.  Secondary:   Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score   [ Time Frame: 12 months ]

14.  Secondary:   Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score   [ Time Frame: 12 months ]

15.  Secondary:   Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score   [ Time Frame: 12 months ]

16.  Secondary:   Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score   [ Time Frame: 12 months ]

17.  Secondary:   Acute Procedural Success for Astron and Pulsar Stent   [ Time Frame: 30 days ]

18.  Secondary:   Clinical Success   [ Time Frame: 30 days ]

19.  Secondary:   Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates   [ Time Frame: 12 month ]

20.  Secondary:   Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate   [ Time Frame: 30 days ]

21.  Secondary:   Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months   [ Time Frame: 12 months ]

22.  Secondary:   Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months   [ Time Frame: 12 months ]

23.  Secondary:   Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months   [ Time Frame: 12 months ]

24.  Secondary:   Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success   [ Time Frame: Acute / Date of Procedure ]

25.  Secondary:   Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success   [ Time Frame: 30 days ]

26.  Secondary:   Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate   [ Time Frame: 12 months ]

27.  Secondary:   Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months   [ Time Frame: 12 months ]

28.  Secondary:   Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months   [ Time Frame: 12 months ]

29.  Secondary:   Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months   [ Time Frame: 12 months ]

30.  Secondary:   Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months   [ Time Frame: 12 months ]

31.  Secondary:   Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success   [ Time Frame: Acute / Date of Procedure ]

32.  Secondary:   Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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


Publications:

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01319812     History of Changes
Other Study ID Numbers: BIOFLEX-I
Study First Received: March 18, 2011
Results First Received: September 2, 2016
Last Updated: May 3, 2017