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Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon (ILLUMENATE)

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ClinicalTrials.gov Identifier: NCT01858428
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Results First Posted : January 17, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Interventions: Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Device: EverCross Percutaneous Transluminal Balloon Catheter

  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
Randomization. Patients who provided written informed consent but were excluded from the study due to not meeting all of the inclusion criteria or meeting one or more of the exclusion criteria were screen failures. Subjects who had unsuccessful pre-dilatation were not randomized and were to be treated per the institution’s standard of care.

Reporting Groups
  Description
Bare PTA EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
Drug-Coated PTA Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Participant Flow:   Overall Study
    Bare PTA   Drug-Coated PTA
STARTED   100 [1]   200 
COMPLETED   99   190 
NOT COMPLETED   1   10 
[1] EverCross™ Balloon Catheter now a product of Medtronic



  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
Bare PTA EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
Drug-Coated PTA Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Total Total of all reporting groups

Baseline Measures
   Bare PTA   Drug-Coated PTA   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   200   300 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
     
Age       
Participants Analyzed 
[Units: Participants]
 100   200   300 
Age   69.8  (9.8)   68.3  (10.3)   68.8  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 100   200   300 
Female      36  36.0%      88  44.0%      124  41.3% 
Male      64  64.0%      112  56.0%      176  58.7% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native       
Participants Analyzed 
[Units: Participants]
 96   190   286 
American Indian or Alaska Native   0   2   2 
Asian       
Participants Analyzed 
[Units: Participants]
 96   190   286 
Asian   1   2   3 
Black or African American       
Participants Analyzed 
[Units: Participants]
 96   190   286 
Black or African American   19   35   54 
White       
Participants Analyzed 
[Units: Participants]
 96   190   286 
White   68   142   210 
Other       
Participants Analyzed 
[Units: Participants]
 96   190   286 
Other   8   9   17 
[1] Not all participants disclosed race or ethnicity.
Region of Enrollment 
[Units: Participants]
     
Austria       
Participants Analyzed 
[Units: Participants]
 100   200   300 
Austria   10   17   27 
United States       
Participants Analyzed 
[Units: Participants]
 100   200   300 
United States   90   183   273 
Ankle-Brachial Index [1] 
[Units: Ratio]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 100   200   300 
   0.76  (0.20)   0.75  (0.21)   0.75  (0.21) 
[1] The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Rutherford Becker Clinical Category [1] 
[Units: Participants]
     
Rutherford 2       
Participants Analyzed 
[Units: Participants]
 100   200   300 
Rutherford 2   35   63   98 
Rutherford 3       
Participants Analyzed 
[Units: Participants]
 100   200   300 
Rutherford 3   60   129   189 
Rutherford 4       
Participants Analyzed 
[Units: Participants]
 100   200   300 
Rutherford 4   5   8   13 
[1]

Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.

Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease

  1. Mild claudication
  2. Moderate claudication
  3. Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia.


  Outcome Measures

1.  Primary:   Patency at 12 Month Post-procedure   [ Time Frame: 12 months ]

2.  Primary:   Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization   [ Time Frame: 30 Days and 12 months ]

3.  Secondary:   Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure   [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ]

4.  Secondary:   Rate of Vascular Access and Bleeding Complications   [ Time Frame: in-hospital and 1, 6, 12 and 24 months ]

5.  Secondary:   Rate of Clinically-driven Target Lesion Revascularization   [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]

6.  Secondary:   Rate of Target Lesion Revascularization   [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]

7.  Secondary:   Rate of Target Limb Major Amputation   [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ]

8.  Secondary:   Mortality Rate   [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]

9.  Secondary:   Rate of Occurrence of Arterial Thrombosis of the Treated Segment   [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ]

10.  Secondary:   Patency Rate and Freedom From Clinically-driven TLR   [ Time Frame: 6, 24 and 36 months ]

11.  Secondary:   Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%   [ Time Frame: procedure, Day 0 ]

12.  Secondary:   Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%   [ Time Frame: procedure, Day 0 ]

13.  Secondary:   Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure   [ Time Frame: procedure, Day 0 ]

14.  Secondary:   Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure   [ Time Frame: procedure, Day 0 ]

15.  Secondary:   Change in Ankle-brachial Index (ABI) From Pre-procedure   [ Time Frame: 6, 12, 24 and 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 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: Julie Wolfram Smith
Organization: Spectranetics
phone: 763-955-1072
e-mail: julie.wolframsmith@spnc.com


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

Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01858428     History of Changes
Other Study ID Numbers: TP-1397
First Submitted: May 8, 2013
First Posted: May 21, 2013
Results First Submitted: October 3, 2017
Results First Posted: January 17, 2018
Last Update Posted: February 21, 2018