Trial record 1 of 10 for:    EXCITE ISR
Previous Study | Return to List | Next Study

Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis (EXCITE ISR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT01330628
First received: April 4, 2011
Last updated: July 19, 2016
Last verified: July 2016
Results First Received: May 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Interventions: Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
Procedure: Balloon angioplasty

  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
Laser Atherectomy and PTA

laser, then balloon angioplasty

Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty

Balloon Angioplasty Balloon angioplasty: standard balloon catheters for PTA

Participant Flow:   Overall Study
    Laser Atherectomy and PTA     Balloon Angioplasty  
STARTED     170     82  
30 Day Follow-up     165     73  
6 Month Follow-up     135     60  
COMPLETED     100     42  
NOT COMPLETED     70     40  
Death                 2                 3  
Lost to Follow-up                 5                 6  
Adverse Event                 44                 25  
Withdrawn                 18                 6  
Didn't receive study treatment                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Laser Atherectomy and PTA

laser, then balloon angioplasty

Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty

Balloon Angioplasty Balloon angioplasty: standard balloon catheters for PTA
Total Total of all reporting groups

Baseline Measures
    Laser Atherectomy and PTA     Balloon Angioplasty     Total  
Number of Participants  
[units: participants]
  170     82     252  
Age  
[units: years]
Mean (Standard Deviation)
  68.6  (9.8)     67.9  (10.3)     68.4  (9.9)  
Gender  
[units: participants]
     
Female     64     31     95  
Male     106     51     157  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     21     12     33  
Not Hispanic or Latino     149     70     219  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     22     8     30  
White     144     74     218  
More than one race     2     0     2  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     170     82     252  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Freedom From Target Lesion Revascularization (TLR)   [ Time Frame: 6 months ]

2.  Primary:   Freedom From Major Adverse Events (MAE)   [ 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
No text entered.


  More Information
  Hide 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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Amanda Johnson, VP of Regulatory & Medical Affairs
Organization: Spectranetics
phone: (719) 447-2000
e-mail: amanda.johnson@spnc.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01330628     History of Changes
Other Study ID Numbers: D013474
Study First Received: April 4, 2011
Results First Received: May 4, 2016
Last Updated: July 19, 2016
Health Authority: United States: Food and Drug Administration