NCT01454778

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 24, 2016

Completed
Last Updated

May 24, 2016

Status Verified

April 1, 2016

Enrollment Period

3.5 years

First QC Date

April 4, 2011

Results QC Date

August 12, 2015

Last Update Submit

April 15, 2016

Conditions

Peripheral Vascular Disease

Keywords

restenosisperipheral vascular diseaselower extremity ischemiaclaudication

Outcome Measures

Primary Outcomes (2)

  • Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 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

    10 months

  • Rutherford Classification of Peripheral Arterial Disease

    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

    10 months

Secondary Outcomes (4)

  • Freedom From Amputation Event

    up to 10 months

  • Freedom From Target Vessel Revascularization Event

    up to 10 months

  • Freedom From Binary Restenosis

    10 months

  • Number of Serious Adverse Events

    Up to 19 months

Study Arms (1)

Paclitaxel

EXPERIMENTAL
Drug: Paclitaxel

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

Also known as: Taxol, Onxol
Paclitaxel

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ability to provide informed consent
  • age 18-90 years old
  • Rutherford 1-6
  • occlusion or stenosis in the infrainguinal vessels

You may not qualify if:

  • inability to pass the guide wire across the lesion
  • pregnant or lactating women
  • specific limb has not been previously treated with endovascular intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford Vascular Associates

Sioux Falls, South Dakota, 57117, United States

Location

MeSH Terms

Conditions

Peripheral Vascular DiseasesIntermittent Claudication

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseaseSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Dr. Patrick Kelly
Organization
Sanford Health
Patrick.Kelly@SanfordHealth.org
605-312-7300

Study Officials

  • Patrick Kelly, MD

    Sanford Vascular Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2011

First Posted

October 19, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

May 24, 2016

Results First Posted

May 24, 2016

Record last verified: 2016-04

Locations

US(1)