Paclitaxel Reduces Effects of Intimal Hyperplasia

Peripheral Vascular Disease Clinical Trial

— Pac1  

Official title:

Paclitaxel Reduces Effects of Intimal Hyperplasia Status Post Lower Extremity Revascularization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01454778
• Other study ID #: Pac 1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 4, 2011
• Last updated: December 31, 2014
• Start date: April 2011
• Est. completion date: April 2015

Study information

• Verified date: December 2013
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a single, one time, limited dose infusion of Paclitaxel, that will potentially prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control group at 10 months.

Description:

The investigators study consists of enrolling subjects that are already scheduled to have the blood vessels in their legs re-opened. The entire study is considered standard of care, except the administration of Paclitaxel. Subjects will be consented prior to any study related procedures and prior to procedure. Subjects that meet inclusion/exclusion and the infusion of Paclitaxel has been given, will then be enrolled in the study. After the plaque area has been treated with either angioplasty (inflation of a balloon compacting it against the artery wall), stent (a wire mesh tube that presses the plaque against the artery wall and opens the artery), and/or atherectomy(removal of plaque from the artery), Dr Kelly, Dr. Schultz, Dr, Laurich, or Dr. Santos will then use an infusion balloon (a balloon with an outer layer that has holes that allows a medication to be given) to administer the Paclitaxel. Every time the infusion balloon is blown up, a single dose of medication (Paclitaxel) will be applied to the target lesion. This will be repeated until all of the target lesions have been treated or a maximum dose of 10 mg of Paclitaxel has been given. All persons enrolled in this study will be treated with Paclitaxel. Once the subject is enrolled they will be monitored for a period of 19 months. Subjects are expected to attend all follow up visits. These visits would occur even if the subject were not on the trial. Ankle-brachial index (ABI) (done by measuring blood pressure at the ankle and in the arm while a person is at rest. This test indicates if leg blockages are present) and Duplexes (An ultrasound that measures blood flow rates through the vessels. This test will indicate if leg blockages are present) will be done at the follow up visits. Both of these tests and all follow up visits are considered standard of care and will be charged to the subject or subject's insurance.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• ability to provide informed consent

• age 18-90 years old

• Rutherford 1-6

• occlusion or stenosis in the infrainguinal vessels

Exclusion Criteria:

• inability to pass the guide wire across the lesion

• pregnant or lactating women

• specific limb has not been previously treated with endovascular intervention

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperplasia
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Sanford Vascular Associates	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Patrick Kelly

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of stenosis lower extremity post revascularization up to 19 months	Evidence of stenosis of lower extremity as measured by ABI, Duplex, and Rutherford Classification post revascularization. ABI, Duplex, and Rutherford Classification will be done at 1, 4, 10, and 19 months post revascularization	up to 19 months	Yes
Secondary	Safety (adverse events frequency, severity)		Up to 19 months	Yes
Secondary	Time to Amputation event		up to 19 months	Yes
Secondary	Time to revascularization event		up to 19 months	Yes