IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) (INPACT SFA II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01566461
First received: March 27, 2012
Last updated: July 17, 2015
Last verified: July 2015
Results First Received: February 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Femoral Artery Stenosis
Popliteal Artery Stenosis
Femoral Artery Occlusion
Popliteal Artery Occlusion
Interventions: Device: Drug-Coated Balloon (DCB)
Device: PTA Balloon: Balloon Angioplasty

  Participant Flow
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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
The IN.PACT SFA Trial was designed as a two-phase randomized trial. IN.PACT SFA I, the first phase, was conducted in Europe with 150 subjects enrolled. IN.PACT SFA II, the second phase, was conducted in the US with 181 subjects enrolled. The randomized data from both phases are pooled and comprise the pivotal trial data.

Reporting Groups
  Description
Drug-Coated Balloon (DCB)

Paclitaxel drug-coated angioplasty balloon

IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm

Standard PTA

Standard angioplasty balloon without Paclitaxel drug-coating

Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm


Participant Flow for 2 periods

Period 1:   IN.PACT SFA I Phase
    Drug-Coated Balloon (DCB)     Standard PTA  
STARTED     99     51  
COMPLETED     88     49  
NOT COMPLETED     11     2  

Period 2:   IN.PACT SFA II Phase
    Drug-Coated Balloon (DCB)     Standard PTA  
STARTED     121     60  
COMPLETED     109     55  
NOT COMPLETED     12     5  



  Baseline Characteristics
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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.
The randomized data (n=331) from both phases have been pooled and comprise the pivotal trial data.

Reporting Groups
  Description
Drug-Coated Balloon (DCB)

Paclitaxel drug-coated angioplasty balloon

IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm

Standard PTA

Standard angioplasty balloon without Paclitaxel drug-coating

Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm

Total Total of all reporting groups

Baseline Measures
    Drug-Coated Balloon (DCB)     Standard PTA     Total  
Number of Participants  
[units: participants]
  220     111     331  
Age  
[units: Years]
Mean (Standard Deviation)
  67.5  (9.5)     68.0  (9.2)     67.6  (9.4)  
Gender  
[units: participants]
     
Female     77     36     113  
Male     143     75     218  



  Outcome Measures
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1.  Primary:   Primary Patency   [ Time Frame: 12 month ]

2.  Primary:   Primary Safety Composite   [ Time Frame: 12 month ]

3.  Secondary:   Major Adverse Event (MAE) Composite   [ Time Frame: 12 month ]

4.  Secondary:   All-cause Death   [ Time Frame: 12 month ]

5.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 12 month ]

6.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 12 month ]

7.  Secondary:   Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)   [ Time Frame: 12 month ]

8.  Secondary:   Major Target Limb Amputation   [ Time Frame: 12 month ]

9.  Secondary:   Thrombosis at the Target Lesion   [ Time Frame: 12 month ]

10.  Secondary:   Primary Sustained Clinical Improvement   [ Time Frame: 12 month ]

11.  Secondary:   Secondary Sustained Clinical Improvement   [ Time Frame: 12 month ]

12.  Secondary:   Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)   [ Time Frame: 12 month ]

13.  Secondary:   Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)   [ Time Frame: 12 month ]

14.  Secondary:   Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)   [ Time Frame: 12 month ]

15.  Secondary:   Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)   [ Time Frame: From baseline to 12 month ]

16.  Secondary:   Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)   [ Time Frame: 12 month ]

17.  Secondary:   Device Success   [ Time Frame: Day 1 ]

18.  Secondary:   Procedural Success   [ Time Frame: Day 1 ]

19.  Secondary:   Clinical Success   [ Time Frame: Day 1 ]

20.  Secondary:   Days of Hospitalization Due to the Index Lesion   [ Time Frame: 12 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Beaux S. Alexander, Clinical Research Director, Peripheral Clinical
Organization: Medtronic Endovascular Therapies
phone: 707-591-7291
e-mail: beaux.s.alexander@medtronic.com


No publications provided by Medtronic Endovascular

Publications automatically indexed to this study:

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01566461     History of Changes
Other Study ID Numbers: 10031540DOC
Study First Received: March 27, 2012
Results First Received: February 18, 2015
Last Updated: July 17, 2015
Health Authority: United States: Food and Drug Administration