Determining Predictors of Restenosis in Femoropopliteal Lesions

Not Applicable

• Conditions: Peripheral Vascular Disease
• Interventions: Device: Ultrasound

• Registration Number: NCT02734095
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-23
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-11
• Last Update Submitted: 2016-04-11
• Study First Posted: 2016-04-12
• Last Update Posted: 2016-04-12
• Study Start: 2016-08
• Primary Completion: 2017-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravascular Ultrasound data	Ultrasound	Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Primary Outcome Measures

Name	Time	Method
In Stent Restenosis	12 months (±30 days)
Stent Expansion Ratio Measure	intraoperative	defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area
Axial Stent Symmetry Index Measure	intraoperative	defined as = minimum ÷ maximum stent cross-sectional area
Stent/reference Diameter Ratio Measure	intraoperative	defined as = stent diameter ÷ reference diameter
Plaque Burden Measure	intraoperative	defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area
Radial Stent Symmetry Index Measure	intraoperative	defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area
Reference Lumen Measure	intraoperative	defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5
Reference Diameter Measure	intraoperative	defined as = (proximal reference diameter + distal reference diameter) x 0.5

Secondary Outcome Measures

Name	Time	Method
Freedom of reintervention at each follow-up	12 months (±30 days)	defined as freedom from target lesion revascularization (TLR)
Technical success	intraoperative	defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater tha 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging.
Limb-salvage rate	12 months (±30 days)	defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)
Clinical success at follow-up	12 months (±30 days)	defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Serious adverse events	12 months (±30 days)	defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.