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Atrium iCAST Iliac Stent Pivotal Study (iCARUS)

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ClinicalTrials.gov Identifier: NCT00593385
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Peripheral Vascular Disease
Intervention: Device: iCAST covered stent

  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
Device: ICAST Covered Stent Implantation of ≥ 1 ICAST stent

Participant Flow:   Overall Study
    Device: ICAST Covered Stent
STARTED   165 
Intention to Treat (ITT) Population [1]   152 [2] 
COMPLETED   125 [3] 
NOT COMPLETED   40 
Death                14 
Lost to Follow-up                17 
Withdrawal by Subject                9 
[1] Subjects who signed written informed consent, enrolled in the study and met study entry criteria.
[2] Excludes 13 subjects who did not meet inclusion/exclusion criteria.
[3] 125 of 165 enrolled patients completed the study.



  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.
ITT population was assessed for baseline measures: this includes subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.

Reporting Groups
  Description
Device: ICAST Covered Stent Implantation of ≥ 1 ICAST stent

Baseline Measures
   Device: ICAST Covered Stent 
Overall Participants Analyzed 
[Units: Participants]
 152 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   152 
   65.23  (9.96) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
Female      58  38.2% 
Male      94  61.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
Hispanic or Latino      3   2.0% 
Not Hispanic or Latino      149  98.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      8   5.3% 
White      142  93.4% 
More than one race      2   1.3% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   152 
United States   132 
Germany   
Participants Analyzed   152 
Germany   20 
Cigarette Smoking Status [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   151 
Current smoker      76  50.3% 
Former smoker      62  41.1% 
Non-smoker      13   8.6% 
Unknown      0   0.0% 
[1] One subject was missing data.
Previous Peripheral Artery Revascularization/Surgery [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   150 
   25 
[1] Two subjects were missing data.
Coronary Artery Disease [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   151 
   77 
[1] One subject was missing data.
Previous Myocardial Infarction (MI) [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   151 
   35 
[1] One subject was missing data.
Previous percutaneous coronary revascularization [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   151 
   39 
[1] One subject was missing data.
Coronary Artery Bypass Graft Surgery [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   151 
   34 
[1] One subject was missing data.
Cerebrovascular Accident 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
   11 
Previous Amputation 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
   2 
Transient Ischemic Attack [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   151 
   7 
[1] One subject was missing data.
Diabetes Mellitus 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
   56 
Hypertension 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
   129 
Hypercholesterolemia 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
   130 
Renal Insufficiency 
[Units: Participants]
Count of Participants
 
Participants Analyzed   152 
   19 


  Outcome Measures

1.  Primary:   Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis   [ Time Frame: Within 9 Months post-procedure ]

2.  Secondary:   Acute Procedural Success   [ Time Frame: Post-procedure ]

3.  Secondary:   Device Success   [ Time Frame: Post-procedure ]

4.  Secondary:   Major Adverse Event (MAE)   [ Time Frame: 30 Days ]

5.  Secondary:   Major Adverse Vascular Event (MAVE)   [ Time Frame: 30 Days ]

6.  Secondary:   Major Adverse Vascular Event (MAVE)   [ Time Frame: 180 Days ]

7.  Secondary:   Major Adverse Vascular Event (MAVE)   [ Time Frame: 270 Days ]

8.  Secondary:   Major Adverse Vascular Event (MAVE)   [ Time Frame: 360 Days ]

9.  Secondary:   Early Clinical Success   [ Time Frame: 1 Month ]

10.  Secondary:   Late Clinical Success   [ Time Frame: 6 Months ]

11.  Secondary:   Late Clinical Success   [ Time Frame: 9 Months ]

12.  Secondary:   Late Clinical Success   [ Time Frame: 12 Months ]

13.  Secondary:   Late Clinical Success   [ Time Frame: 24 Months ]

14.  Secondary:   Late Clinical Success   [ Time Frame: 36 Months ]

15.  Secondary:   Primary Patency   [ Time Frame: 1 Month ]

16.  Secondary:   Primary Patency   [ Time Frame: 6 Months ]

17.  Secondary:   Primary Patency   [ Time Frame: 9 Months ]

18.  Secondary:   Primary Patency   [ Time Frame: 12 Months ]

19.  Secondary:   Primary Patency   [ Time Frame: 24 Months ]

20.  Secondary:   Primary Patency   [ Time Frame: 36 Months ]

21.  Secondary:   Primary-Assisted Patency   [ Time Frame: 1 Month ]

22.  Secondary:   Primary-Assisted Patency   [ Time Frame: 6 Months ]

23.  Secondary:   Primary-Assisted Patency   [ Time Frame: 9 Months ]

24.  Secondary:   Primary-Assisted Patency   [ Time Frame: 12 Months ]

25.  Secondary:   Primary-Assisted Patency   [ Time Frame: 24 Months ]

26.  Secondary:   Primary-Assisted Patency   [ Time Frame: 36 Months ]

27.  Secondary:   Secondary Patency   [ Time Frame: 1 Month ]

28.  Secondary:   Secondary Patency   [ Time Frame: 6 Months ]

29.  Secondary:   Secondary Patency   [ Time Frame: 9 Months ]

30.  Secondary:   Secondary Patency   [ Time Frame: 12 Months ]

31.  Secondary:   Secondary Patency   [ Time Frame: 24 Months ]

32.  Secondary:   Secondary Patency   [ Time Frame: 36 Months ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Elizabeth Bulger, Director of Clinical Affairs
Organization: Getinge
phone: 1-603-864-5368
e-mail: elizabeth.bulger@getinge.com



Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00593385     History of Changes
Other Study ID Numbers: Atrium 701
First Submitted: January 2, 2008
First Posted: January 15, 2008
Results First Submitted: February 12, 2018
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018