Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses (XPEDITE)

Cook Group

Status: Completed

Conditions: Peripheral Arterial Disease (PAD)

Treatments: Device: Zilver® Paclitaxel-Eluting Peripheral Stent; Device: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating; Device: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Study type: Interventional

Funder types: Industry

Identifiers

NCT02936622

13-002

Details and patient eligibility

About

This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
• Symptoms of peripheral arterial disease (Rutherford 2-4)

Exclusion criteria

• Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
• Less than 18 years old
• Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
• Previous stent in the study vessel

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 3 patient groups

Stent 1

Experimental group

Description:

Zilver® PTX Stent

Treatment:

Device: Zilver® Paclitaxel-Eluting Peripheral Stent

Stent 2

Experimental group

Description:

Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Treatment:

Device: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Stent 3

Experimental group

Description:

Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Treatment:

Device: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating