Determining Predictors of Restenosis in Femoropopliteal Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-09-30

Brief Summary

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A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

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Detailed Description

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Intravascular ultrasound is considered important tool in endovascular procedures of coronary territory. Information such as vessel diameter, stent expansion, residual stenosis, helped in better understanding of the disease, treatment and stent behavior.

However, as a different anatomical territory with major hemodynamic differences, many of these concepts could not be reproduced in the femoropopliteal segment.

The purpose of this study is to correlate data collected by intraoperative intravascular ultrasound after the angioplasty procedure with stent placement in femoropopliteal arterial lesions and patency of this revascularization within 12 months.

Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intravascular Ultrasound data

Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Interventions

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Ultrasound

Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Stenotic (\>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries;
* Successful lesion passage passed with conventional mechanical guidewires;
* Symptomatic critical limb ischemia (Rutherford 4, 5, 6);
* Life-expectancy of more than 12 months;
* Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study;
* Te patient must provide written patient informed consent that is approved by the ethics committee.

Exclusion Criteria

* Patient refusing treatment;
* The reference segment diameter is not suitable fo available balloon and/or stent design;
* Unsuccessfully treated (\>30% residual stenosis) proximal inflow limiting arterial stenosis;
* Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site;
* The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies;
* The patent has a history of prior life-threatening contrast media reaction;
* The patient is currently enrolled in another investigational device or drug trial;
* The patient is currently breast-feeding, pregnant or intends to become pregnant;
* The patient is mentally ill or retarded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No