Paclitaxel Eluting Balloon for SFA In-stent Restenosis

Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01616888

Enrollment

Registered

2012-06-12

Start date

2012-06-30

Completion date

2015-08-31

Last updated

2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In-stent Arterial Restenosis

Keywords

drug eluting balloon with paclitaxel, in stent restenosis, femoropopliteal arteries, angioplasty

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.

Detailed description

Peripheral artery disease (PAD) in the lower extremities can cause claudication, pain in the legs or feet and slowly wounds that can affect patients' quality of life and increase the risk of leg amputation and death. Both conventional balloon angioplasty (CBA) alone and CBA plus bare metal stents are the current primary endovascular therapy to treat PAD. However, exaggerated neointimal hyperplasia leading to in-stent restenosis is associated with CBA. Paclitaxel coated balloons have been recognized to be safe and effective for the treatment of coronary in-stent restenosis, which the investigators hypothesize to be applicable in femoropopliteal cases.

Interventions

DEVICEPTA with drug eluting balloon with paclitaxel

Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Target lesion patency at 6-month follow-up.	6-month post index procedure	Patency of target lesion at 6-month follow-up based on duplex ultrasound.

Secondary

Measure	Time frame	Description
Clinical success up to 12 months post index procedure	12 months post index procedure	Improvement on clinical evaluations including staging of PAD according to the Rutherford category, ABI at 1, 6, 12 months post procedure compared to baseline assessment.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026