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Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

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ClinicalTrials.gov Identifier: NCT00435942
Recruitment Status : Completed
First Posted : February 16, 2007
Results First Posted : September 5, 2017
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Bolton Medical

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Thoracic Aortic Aneurysms
and Penetrating Atherosclerotic Ulcers
Interventions: Device: Relay Thoracic Stent-Graft
Procedure: Open Repair

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects screened and enrolled at 29 sites in the United States

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
Relay Device Group Endovascular Treatment arm
Surgical Control Group Open Surgical Repair arm

Participant Flow:   Overall Study
    Relay Device Group   Surgical Control Group
STARTED   120   60 
COMPLETED [1]   97   33 
NOT COMPLETED   23   27 
Death                17                10 
Withdrawal by Subject                2                0 
Lost to Follow-up                0                16 
Conversion to Open Repair                1                0 
Technical Failure                3                0 
Other                0                1 
[1] 97 patients



  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
Relay Device Group Endovascular Treatment arm
Surgical Control Group Open Surgical Repair arm
Total Total of all reporting groups

Baseline Measures
   Relay Device Group   Surgical Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   60   180 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      21  17.5%      12  20.0%      33  18.3% 
>=65 years      99  82.5%      48  80.0%      147  81.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.8  (11.02)   70.0  (9.17)   71.84  (10.39) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      58  48.3%      20  33.3%      78  43.3% 
Male      62  51.7%      40  66.7%      102  56.7% 
Region of Enrollment 
[Units: Participants]
     
United States   120   60   180 


  Outcome Measures

1.  Primary:   Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects   [ Time Frame: 1 year ]

2.  Primary:   Primary Safety Endpoint: Distribution of Major Adverse Events   [ Time Frame: 1 year ]


  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
Many subjects experienced more than one type of event.


  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: Annie Weiller
Organization: Bolton Medical, Inc.
phone: 954-838-9699
e-mail: AWeiller@boltonmedical.com



Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT00435942     History of Changes
Obsolete Identifiers: NCT00998491
Other Study ID Numbers: IP-0004-06
First Submitted: February 14, 2007
First Posted: February 16, 2007
Results First Submitted: September 23, 2013
Results First Posted: September 5, 2017
Last Update Posted: January 16, 2018