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Multi-center Study for Stent Graft System for Peripheral Artery (VJH11-01)

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ClinicalTrials.gov Identifier: NCT01575808
Recruitment Status : Active, not recruiting
First Posted : April 11, 2012
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Intervention: Device: GP1101

  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
133 participants were enrolled into the GP1101 arm; 14 were training cases, 16 were excluded by the Case Conference Committee; total participants started was 103. Retrospective Surgical Bypass Outcomes represent historical controls (n=68).

Reporting Groups
  Description
GP1101

Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >

> GP1101: Endovascular Device Implantation

Retrospective Surgical Bypass Outcomes Retrospective data collection (Apr 2012 - Apr 2014) surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.

Participant Flow:   Overall Study
    GP1101   Retrospective Surgical Bypass Outcomes
STARTED   103   68 
COMPLETED   100 [1]   68 
NOT COMPLETED   3   0 
Death                2                0 
Withdrawal by Subject                1                0 
[1] Study ongoing. All 103 assessed for primary invasiveness endpoints,100 for primary efficacy endpoint



  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.
No text entered.

Reporting Groups
  Description
GP1101 Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
Retrospective Surgical Bypass Outcomes Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
Total Total of all reporting groups

Baseline Measures
   GP1101   Retrospective Surgical Bypass Outcomes   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   68   171 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   103   68   171 
   74.2  (7.0)   72.3  (8.3)   73.4  (7.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
Female      18  17.5%      17  25.0%      35  20.5% 
Male      85  82.5%      51  75.0%      136  79.5% 
Region of Enrollment 
[Units: Participants]
     
Japan       
Participants Analyzed   103   68   171 
Japan   103   68   171 
Height [1] 
[Units: Centimeter]
Mean (Standard Deviation)
     
Participants Analyzed   103   0   103 
   161.9  (8.48)      161.9  (8.48) 
[1] Height was not measured in the Retrospective Surgical Bypass Outcomes arm
Weight [1] 
[Units: Kilograms]
Mean (Standard Deviation)
     
Participants Analyzed   103   0   103 
   59.2  (10.03)      59.2  (10.03) 
[1] Weight was not measured in the Retrospective Surgical Bypass Outcomes arm
BMI [1] [2] 
[Units: Kg/㎡]
Mean (Standard Deviation)
     
Participants Analyzed   103   0   103 
   22.5  (2.83)      22.5  (2.83) 
[1] Body Mass Index
[2] BMI was not measured in the Retrospective Surgical Bypass Outcomes arm
Smoking History 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
Current Smoker      29  28.2%      23  33.8%      52  30.4% 
Not a Current Smoker      74  71.8%      45  66.2%      119  69.6% 
Diabetes Mellitus 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
History of Diabetes Mellitus = Yes      62  60.2%      34  50.0%      96  56.1% 
History of Diabetes Mellitus = No      41  39.8%      34  50.0%      75  43.9% 
Hypertension 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
History of Hypertension = Yes      91  88.3%      59  86.8%      150  87.7% 
History of Hypertension = No      12  11.7%      9  13.2%      21  12.3% 
Dyslipidemia 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
History of Dyslipidemia = Yes      64  62.1%      32  47.1%      96  56.1% 
History of Dyslipidemia = No      39  37.9%      36  52.9%      75  43.9% 
Carotid Disease 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
History of Carotid Disease = Yes      13  12.6%      6   8.8%      19  11.1% 
History of Carotid Disease = No      90  87.4%      62  91.2%      152  88.9% 
Coronary Artery Disease 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
History of Coronary Artery Disease = Yes      42  40.8%      21  30.9%      63  36.8% 
History of Coronary Artery Disease = No      61  59.2%      47  69.1%      108  63.2% 
Myocardial Infarction 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
History of Myocardial Infarction = Yes      12  11.7%      7  10.3%      19  11.1% 
History of Myocardial Infarction - No      91  88.3%      61  89.7%      152  88.9% 
Congestive Heart Failure 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
History of Congestive Heart Failure = Yes      4   3.9%      3   4.4%      7   4.1% 
HIstory of Congestive Heart Failure = No      99  96.1%      65  95.6%      164  95.9% 
Chronic Obstructive Pulmonary Disease (COPD) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
History of COPD = Yes      10   9.7%      4   5.9%      14   8.2% 
History of COPD = No      93  90.3%      64  94.1%      157  91.8% 
Study Limb 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
Right      56  54.4%      32  47.1%      88  51.5% 
Left      47  45.6%      36  52.9%      83  48.5% 
Ankle Brachial Index (ABI) [1] 
[Units: Ratio]
Mean (Standard Deviation)
     
Participants Analyzed   102   68   170 
   0.64  (0.12)   0.47  (0.20)   0.57  (0.18) 
[1] Eligibility met by TBI for one subject.
Rutherford Category 
[Units: Participants]
Count of Participants
     
Participants Analyzed   103   68   171 
Category 0 - Asymptomatic      0   0.0%      0   0.0%      0   0.0% 
Category 1 - Mild Claudication      0   0.0%      0   0.0%      0   0.0% 
Category 2 - Moderate Claudication      45  43.7%      7  10.3%      52  30.4% 
Category 3 - Severe Claudication      55  53.4%      44  64.7%      99  57.9% 
Category 4 - Ischemic Rest Pain      1   1.0%      7  10.3%      8   4.7% 
Category 5 - Minor Tissue Loss      2   1.9%      10  14.7%      12   7.0% 
Category 6- Major Tissue Loss      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Primary Assisted Patency   [ Time Frame: 12 months ]

2.  Primary:   Duration of Stay   [ Time Frame: Up to discharge ]

3.  Primary:   Rate of Avoidance of General Anesthesia   [ Time Frame: Day 0 ]

4.  Secondary:   Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)   [ Time Frame: 1 month ]

5.  Secondary:   Percent of Participants Not Experiencing an Adverse Event   [ Time Frame: 1 month ]

6.  Secondary:   Percent of Participants Not Experiencing an Adverse Event   [ Time Frame: 3 months ]

7.  Secondary:   Percent of Participants Not Experiencing an Adverse Event   [ Time Frame: 6 months ]

8.  Secondary:   Percent of Participants Not Experiencing an Adverse Event   [ Time Frame: 12 months ]

9.  Secondary:   Technical Success   [ Time Frame: Post-procedure ]

10.  Secondary:   Primary Patency   [ Time Frame: 1 month ]

11.  Secondary:   Primary Patency   [ Time Frame: 3 months ]

12.  Secondary:   Primary Patency   [ Time Frame: 6 months ]

13.  Secondary:   Primary Patency   [ Time Frame: 12 months ]

14.  Secondary:   Secondary Patency   [ Time Frame: 1 month ]

15.  Secondary:   Secondary Patency   [ Time Frame: 3 months ]

16.  Secondary:   Secondary Patency   [ Time Frame: 6 months ]

17.  Secondary:   Secondary Patency   [ Time Frame: 12 months ]

18.  Secondary:   Rate of Avoidance of Stent Fracture   [ Time Frame: 1 month ]

19.  Secondary:   Rate of Avoidance of Stent Fracture   [ Time Frame: 3 months ]

20.  Secondary:   Rate of Avoidance of Stent Fracture   [ Time Frame: 6 months ]

21.  Secondary:   Rate of Avoidance of Stent Fracture   [ Time Frame: 12 months ]

22.  Secondary:   Avoidance of Target Lesion Revascularization   [ Time Frame: 1 month ]

23.  Secondary:   Avoidance of Target Lesion Revascularization   [ Time Frame: 3 months ]

24.  Secondary:   Avoidance of Target Lesion Revascularization   [ Time Frame: 6 months ]

25.  Secondary:   Avoidance of Target Lesion Revascularization   [ Time Frame: 12 months ]

26.  Secondary:   Clinical Success   [ Time Frame: 1 month ]

27.  Secondary:   Clinical Success   [ Time Frame: 3 months ]

28.  Secondary:   Clinical Success   [ Time Frame: 6 months ]

29.  Secondary:   Clinical Success   [ Time Frame: 12 months ]

30.  Secondary:   Change in Ankle-Brachial Index From Baseline   [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented ]

31.  Secondary:   Change in Ankle-Brachial Index From Baseline   [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented ]

32.  Secondary:   Change in Ankle-Brachial Index From Baseline   [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented ]

33.  Secondary:   Change in Ankle-Brachial Index From Baseline   [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented ]

34.  Secondary:   Vascular Quality of Life Questionnaire - VascuQOL   [ Time Frame: 1 month ]

35.  Secondary:   Vascular Quality of Life Questionnaire - VascuQOL   [ Time Frame: 3 months ]

36.  Secondary:   Vascular Quality of Life Questionnaire - VascuQOL   [ Time Frame: 6 months ]

37.  Secondary:   Vascular Quality of Life Questionnaire - VascuQOL   [ Time Frame: 12 months ]

38.  Secondary:   Walking Impairment Questionnaire-WIQ   [ Time Frame: 1 month ]

39.  Secondary:   Walking Impairment Questionnaire-WIQ   [ Time Frame: 3 months ]

40.  Secondary:   Walking Impairment Questionnaire-WIQ   [ Time Frame: 6 months ]

41.  Secondary:   Walking Impairment Questionnaire-WIQ   [ Time Frame: 12 months ]

42.  Secondary:   Rate of Avoidance of Blood Transfusion   [ Time Frame: Post-Procedure ]

43.  Secondary:   Percent of Participants Not Experiencing an Adverse Event   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

44.  Secondary:   Percent of Participants Not Experiencing an Adverse Event   [ Time Frame: 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

45.  Secondary:   Percent of Participants Not Experiencing an Adverse Event   [ Time Frame: 48 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

46.  Secondary:   Rate of Avoidance of Adverse Events   [ Time Frame: 60 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

47.  Secondary:   Primary Patency   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

48.  Secondary:   Secondary Patency   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

49.  Secondary:   Rate of Avoidance of Stent Fracture   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

50.  Secondary:   Avoidance of Target Lesion Revascularization   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

51.  Secondary:   Clinical Success   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

52.  Secondary:   Change in Ankle-Brachial Index From Baseline   [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

53.  Secondary:   Vascular Quality of Life Questionnaire - VascuQOL   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

54.  Secondary:   Walking Impairment Questionnaire-WIQ   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Takao Ohki
Organization: Toyko Jikei University Hospital
phone: 81-090-2478-8304
e-mail: takohki@msn.com



Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01575808     History of Changes
Other Study ID Numbers: VJH11-01
First Submitted: April 9, 2012
First Posted: April 11, 2012
Results First Submitted: April 7, 2017
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018