Determining Predictors of Restenosis in Femoropopliteal Lesions

University of Campinas, Brazil

Status

Unknown

Conditions

Peripheral Vascular Disease

Treatments

Device: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT02734095

52994416.7.0000.5404

Details and patient eligibility

About

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

Full description

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.