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Effects of Paclitaxel on Intimal Hyperplasia (Pac1)

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ClinicalTrials.gov Identifier: NCT01454778
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : May 24, 2016
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Patrick Kelly, Sanford Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Peripheral Vascular Disease
Intervention Drug: Paclitaxel
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paclitaxel
Hide Arm/Group Description

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
Period Title: Overall Study
Started 50
Completed 47
Not Completed 3
Reason Not Completed
Lost to Follow-up             2
Death             1
Arm/Group Title Paclitaxel
Hide Arm/Group Description

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
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants
71.5
(44 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
15
  30.0%
Male
35
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months
Hide Description The Ankle-Brachial Index is calculated as a ratio of the ankle blood pressure and the arm blood pressure. The ABI and Rutherford Classification will be assessed at 10 months post revascularization
Time Frame 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel coating 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
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: ratio
0.93  (0.22)
2.Primary Outcome
Title Rutherford Classification of Peripheral Arterial Disease
Hide Description

Evidence of stenosis of lower extremity as measured by the Rutherford Classification post revascularization. The ABI and Rutherford Classification will be assessed at 10 months post revascularization with a lower Rutherford score indicating a better outcome.

0 = Asymptomatic, 1 = Mild Claudication, 2 = Moderate Claudication, 3 = Severe Claudication, 4 = Ischemic Rest Pain, 5 = Minor Tissue Loss, 6 = Ulceration or Gangrene

Time Frame 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel coating 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
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.63  (0.95)
3.Secondary Outcome
Title Freedom From Amputation Event
Hide Description [Not Specified]
Time Frame up to 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel coating 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
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
100
4.Secondary Outcome
Title Freedom From Target Vessel Revascularization Event
Hide Description [Not Specified]
Time Frame up to 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel coating 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
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
86
5.Secondary Outcome
Title Freedom From Binary Restenosis
Hide Description [Not Specified]
Time Frame 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel coating 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
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
80
6.Secondary Outcome
Title Number of Serious Adverse Events
Hide Description [Not Specified]
Time Frame Up to 19 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel coating 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
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Number of SAE's
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel
Hide Arm/Group Description

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
All-Cause Mortality
Paclitaxel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel
Affected / at Risk (%) # Events
Total   2/50 (4.00%)    
Vascular disorders   
Toe embolism  1/50 (2.00%)  1
Restenosis of target lesion  1/50 (2.00%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paclitaxel
Affected / at Risk (%) # Events
Total   37/50 (74.00%)    
Injury, poisoning and procedural complications   
Pain  1/50 (2.00%)  1
Vascular disorders   
Psuedoaneurysm  3/50 (6.00%)  3
DVT  1/50 (2.00%)  1
Occlusion  3/50 (6.00%)  3
Dissection  8/50 (16.00%)  8
Re-stenosis in the treated limb  16/50 (32.00%)  16
Poor wound healing  2/50 (4.00%)  2
Claudication  3/50 (6.00%)  3
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
Responsible Party: Patrick Kelly, Sanford Health
ClinicalTrials.gov Identifier: NCT01454778     History of Changes
Other Study ID Numbers: Pac 1
First Submitted: April 4, 2011
First Posted: October 19, 2011
Results First Submitted: August 12, 2015
Results First Posted: May 24, 2016
Last Update Posted: May 24, 2016