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

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ClinicalTrials.gov Identifier: NCT01330628
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : June 15, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Peripheral Arterial Disease
Interventions Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
Procedure: Balloon angioplasty
Enrollment 252

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laser Atherectomy and PTA Balloon Angioplasty
Hide Arm/Group Description

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: standard balloon catheters for PTA
Period Title: Overall Study
Started 170 82
30 Day Follow-up 165 73
6 Month Follow-up 135 60
Completed 100 42
Not Completed 70 40
Reason Not Completed
Death             2             3
Lost to Follow-up             5             6
Adverse Event             44             25
Withdrawn             18             6
Didn't receive study treatment             1             0
Arm/Group Title Laser Atherectomy and PTA Balloon Angioplasty Total
Hide Arm/Group Description

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: standard balloon catheters for PTA Total of all reporting groups
Overall Number of Baseline Participants 170 82 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 170 participants 82 participants 252 participants
68.6  (9.8) 67.9  (10.3) 68.4  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 82 participants 252 participants
Female
64
  37.6%
31
  37.8%
95
  37.7%
Male
106
  62.4%
51
  62.2%
157
  62.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 82 participants 252 participants
Hispanic or Latino
21
  12.4%
12
  14.6%
33
  13.1%
Not Hispanic or Latino
149
  87.6%
70
  85.4%
219
  86.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 82 participants 252 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.6%
0
   0.0%
1
   0.4%
Native Hawaiian or Other Pacific Islander
1
   0.6%
0
   0.0%
1
   0.4%
Black or African American
22
  12.9%
8
   9.8%
30
  11.9%
White
144
  84.7%
74
  90.2%
218
  86.5%
More than one race
2
   1.2%
0
   0.0%
2
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 170 participants 82 participants 252 participants
170 82 252
1.Primary Outcome
Title Freedom From Target Lesion Revascularization (TLR)
Hide Description Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed for this endpoint does not match with the Participant Flow 6 Month Follow-up population. A subject may not complete a 6 Month Follow-up due to missing the visit, being lost to follow-up, etc., but if they had a TLR prior to this time point, they would still be included in this outcome analysis.
Arm/Group Title Laser Atherectomy and PTA Balloon Angioplasty
Hide Arm/Group Description:

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: standard balloon catheters for PTA
Overall Number of Participants Analyzed 157 73
Measure Type: Number
Unit of Measure: # of participants free from TLR
123 43
2.Primary Outcome
Title Freedom From Major Adverse Events (MAE)
Hide Description Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed for this endpoint does not match with the Participant Flow 30 Day Follow-up population. If a subject did not complete a 30 Day Follow-up due to missing the visit or lost to follow-up, but had an MAE prior to this time point, they would still be included in this outcome analysis.
Arm/Group Title Laser Atherectomy and PTA Balloon Angioplasty
Hide Arm/Group Description:

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: standard balloon catheters for PTA
Overall Number of Participants Analyzed 167 77
Measure Type: Number
Unit of Measure: # of participants free from MAE
158 61
Time Frame Through 1 year
Adverse Event Reporting Description Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
 
Arm/Group Title Laser Atherectomy and PTA Balloon Angioplasty
Hide Arm/Group Description

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: standard balloon catheters for PTA
All-Cause Mortality
Laser Atherectomy and PTA Balloon Angioplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Laser Atherectomy and PTA Balloon Angioplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   117/170 (68.82%)   56/82 (68.29%) 
Blood and lymphatic system disorders     
Blood related disorder SAEs   5/170 (2.94%)  1/82 (1.22%) 
Cardiac disorders     
Cardiac SAEs   19/170 (11.18%)  8/82 (9.76%) 
Gastrointestinal disorders     
Gastrointestinal SAEs   9/170 (5.29%)  6/82 (7.32%) 
General disorders     
Other SAEs   25/170 (14.71%)  12/82 (14.63%) 
Infections and infestations     
Infection SAEs   3/170 (1.76%)  4/82 (4.88%) 
Nervous system disorders     
Neurological SAEs   4/170 (2.35%)  5/82 (6.10%) 
Vascular disorders     
Vascular SAEs   96/170 (56.47%)  48/82 (58.54%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Laser Atherectomy and PTA Balloon Angioplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   88/170 (51.76%)   34/82 (41.46%) 
Blood and lymphatic system disorders     
Blood related disorders   7/170 (4.12%)  5/82 (6.10%) 
Cardiac disorders     
Cardiac   15/170 (8.82%)  4/82 (4.88%) 
Gastrointestinal disorders     
Gastrointestinal   10/170 (5.88%)  3/82 (3.66%) 
General disorders     
Other AEs   40/170 (23.53%)  8/82 (9.76%) 
Infections and infestations     
Infection   9/170 (5.29%)  4/82 (4.88%) 
Nervous system disorders     
Neurological   8/170 (4.71%)  3/82 (3.66%) 
Vascular disorders     
Vascular   53/170 (31.18%)  24/82 (29.27%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Amanda Johnson, VP of Regulatory & Medical Affairs
Organization: Spectranetics
Phone: (719) 447-2000
Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01330628     History of Changes
Other Study ID Numbers: D013474
First Submitted: April 4, 2011
First Posted: April 7, 2011
Results First Submitted: May 4, 2016
Results First Posted: June 15, 2016
Last Update Posted: August 18, 2016