Trial Outcomes & Findings for Effects of Paclitaxel on Intimal Hyperplasia (NCT NCT01454778)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

10 months

Results posted on

2016-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	50
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	2
Overall Study Death	1

Baseline Characteristics

Effects of Paclitaxel on Intimal Hyperplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel n=50 Participants 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
Age, Customized	71.5 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 months

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

Outcome measures

Outcome measures
Measure	Paclitaxel n=50 Participants 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
Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months	0.93 ratio Standard Deviation 0.22

PRIMARY outcome

Timeframe: 10 months

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

Outcome measures

Outcome measures
Measure	Paclitaxel n=50 Participants 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
Rutherford Classification of Peripheral Arterial Disease	0.63 units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: up to 10 months

Outcome measures

Outcome measures
Measure	Paclitaxel n=50 Participants 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
Freedom From Amputation Event	100 percentage of participants

SECONDARY outcome

Timeframe: up to 10 months

Outcome measures

Outcome measures
Measure	Paclitaxel n=50 Participants 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
Freedom From Target Vessel Revascularization Event	86 percentage of participants

SECONDARY outcome

Timeframe: 10 months

Outcome measures

Outcome measures
Measure	Paclitaxel n=50 Participants 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
Freedom From Binary Restenosis	80 percentage of participants

SECONDARY outcome

Timeframe: Up to 19 months

Outcome measures

Outcome measures
Measure	Paclitaxel n=50 Participants 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
Number of Serious Adverse Events	2 Number of SAE's

Adverse Events

Paclitaxel

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paclitaxel n=50 participants at risk 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
Vascular disorders Toe embolism	2.0% 1/50 • Number of events 1
Vascular disorders Restenosis of target lesion	2.0% 1/50 • Number of events 1

Other adverse events

Other adverse events
Measure	Paclitaxel n=50 participants at risk 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
Vascular disorders Psuedoaneurysm	6.0% 3/50 • Number of events 3
Vascular disorders DVT	2.0% 1/50 • Number of events 1
Vascular disorders Occlusion	6.0% 3/50 • Number of events 3
Vascular disorders Dissection	16.0% 8/50 • Number of events 8
Vascular disorders Re-stenosis in the treated limb	32.0% 16/50 • Number of events 16
Vascular disorders Poor wound healing	4.0% 2/50 • Number of events 2
Injury, poisoning and procedural complications Pain	2.0% 1/50 • Number of events 1
Vascular disorders Claudication	6.0% 3/50 • Number of events 3

Additional Information

Dr. Patrick Kelly

Sanford Health

Phone: 605-312-7300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place