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Effects of Paclitaxel on Intimal Hyperplasia (Pac1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Kelly, Sanford Health
ClinicalTrials.gov Identifier:
NCT01454778
First received: April 4, 2011
Last updated: April 15, 2016
Last verified: April 2016
Results First Received: August 12, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Peripheral Vascular Disease
Intervention: Drug: Paclitaxel

  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
No text entered.

Reporting Groups
  Description
Paclitaxel

Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3

Paclitaxel Dosage:

Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*

  • not to exceed 10mg total dose

Participant Flow:   Overall Study
    Paclitaxel  
STARTED     50  
COMPLETED     47  
NOT COMPLETED     3  
Lost to Follow-up                 2  
Death                 1  



  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.
No text entered.

Reporting Groups
  Description
Paclitaxel

Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3

Paclitaxel Dosage:

Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*

  • not to exceed 10mg total dose

Baseline Measures
    Paclitaxel  
Number of Participants  
[units: participants]
  50  
Age, Customized  
[units: years]
Mean (Full Range)
  71.5  
  (44 to 90)  
Gender  
[units: participants]
 
Female     15  
Male     35  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures
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1.  Primary:   Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months   [ Time Frame: 10 months ]

2.  Primary:   Rutherford Classification of Peripheral Arterial Disease   [ Time Frame: 10 months ]

3.  Secondary:   Freedom From Amputation Event   [ Time Frame: up to 10 months ]

4.  Secondary:   Freedom From Target Vessel Revascularization Event   [ Time Frame: up to 10 months ]

5.  Secondary:   Freedom From Binary Restenosis   [ Time Frame: 10 months ]

6.  Secondary:   Number of Serious Adverse Events   [ Time Frame: Up to 19 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Patrick Kelly
Organization: Sanford Health
phone: 605-312-7300
e-mail: Patrick.Kelly@SanfordHealth.org



Responsible Party: Patrick Kelly, Sanford Health
ClinicalTrials.gov Identifier: NCT01454778     History of Changes
Other Study ID Numbers: Pac 1
Study First Received: April 4, 2011
Results First Received: August 12, 2015
Last Updated: April 15, 2016
Health Authority: United States: Institutional Review Board