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Effects of Paclitaxel on Intimal Hyperplasia

NCT01454778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-05-24

Study results available
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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.

Conditions

  • Peripheral Vascular Disease

Interventions

DRUG

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

Sponsors & Collaborators

  • Patrick Kelly

    lead OTHER

Principal Investigators

  • Patrick Kelly, MD · Sanford Vascular Associates

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-10-31
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454778 on ClinicalTrials.gov