CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Paclitaxeldrug
Likely dose
Paclitaxel 3 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01454778
NCT01454778N/ACompleted
CompareCT.gov

Effects of Paclitaxel on Intimal Hyperplasia Status Post Lower Extremity Revascularization

Patrick Kelly·interventional·Posted Oct 19, 2011·Updated May 24, 2016

In Brief

A clinical study evaluating Paclitaxel for Peripheral Vascular Disease. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 19, 2011
Enrollment StartApr 1, 2011
Primary CompletionOct 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 14.7 years ago

Interventions

Paclitaxeldrug

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