NCT01616888

Brief Summary

The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

3 years

First QC Date

June 7, 2012

Last Update Submit

December 5, 2014

Conditions

In-stent Arterial Restenosis

Keywords

drug eluting balloon with paclitaxelin stent restenosisfemoropopliteal arteriesangioplasty

Outcome Measures

Primary Outcomes (1)

  • Target lesion patency at 6-month follow-up.

    Patency of target lesion at 6-month follow-up based on duplex ultrasound.

    6-month post index procedure

Secondary Outcomes (1)

  • Clinical success up to 12 months post index procedure

    12 months post index procedure

Study Arms (1)

Treatment arm

ACTIVE COMPARATOR

SFA angioplasty with In.Pact Admiral drug eluting balloon

Device: PTA with drug eluting balloon with paclitaxel

Interventions

PTA with drug eluting balloon with paclitaxelDEVICE

Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries

Also known as: In.Pact Admiral by Medtronic
Treatment arm

Eligibility Criteria

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

You may qualify if:

  • years or older
  • chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5
  • in-stent restenosis or occlusion in SFA or PPA 20mm - 200mm

You may not qualify if:

  • participation in another investigational drug or device trial
  • life expectancy less than 12 months
  • acute ischemia and/or acute thrombosis of the SFA/PPA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

  • Kong Teng Tan, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 12, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

CA(1)