Determining Predictors of Restenosis in Femoropopliteal Lesions

University of Campinas, Brazil50 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Peripheral Vascular Disease

Interventions

UltrasoundDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Plaque Burden Measure

defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area

Time frame: intraoperative

Reference Lumen Measure

defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5

Time frame: intraoperative

Reference Diameter Measure

defined as = (proximal reference diameter + distal reference diameter) x 0.5

Time frame: intraoperative

Stent/reference Diameter Ratio Measure

defined as = stent diameter ÷ reference diameter

Time frame: intraoperative

Stent Expansion Ratio Measure

defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area

Time frame: intraoperative

Radial Stent Symmetry Index Measure

defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area

Time frame: intraoperative

Axial Stent Symmetry Index Measure

defined as = minimum ÷ maximum stent cross-sectional area

Time frame: intraoperative

In Stent Restenosis

Time frame: 12 months (±30 days)

Secondary Outcomes

Central Contacts

Martin A Geiger, MD

CONTACT

+55 19 35218936 martinandreasgeiger@yahoo.com.br

Data from ClinicalTrials.gov

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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.

Time frame: intraoperative

Freedom of reintervention at each follow-up

defined as freedom from target lesion revascularization (TLR)

Time frame: Baseline

Freedom of reintervention at each follow-up

defined as freedom from target lesion revascularization (TLR)

Time frame: 1 month (± 7 days)

Freedom of reintervention at each follow-up

defined as freedom from target lesion revascularization (TLR)

Time frame: 3 months (±30 days)

Freedom of reintervention at each follow-up

defined as freedom from target lesion revascularization (TLR)

Time frame: 6 months (±30 days)

Freedom of reintervention at each follow-up

defined as freedom from target lesion revascularization (TLR)

Time frame: 12 months (±30 days)

Limb-salvage rate

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)

Time frame: Baseline

Limb-salvage rate

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)

Time frame: 1 month (± 7 days)

Limb-salvage rate

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)

Time frame: 3 months (±30 days)

Limb-salvage rate

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)

Time frame: 6 months (±30 days)

Limb-salvage rate

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)

Time frame: 12 months (±30 days)

Serious adverse events

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.

Time frame: Baseline

Serious adverse events

Time frame: 1 month (± 7 days)

Serious adverse events

Time frame: 3 months (±30 days)

Serious adverse events

Time frame: 6 months (±30 days)

Serious adverse events

Time frame: 12 months (±30 days)

Clinical success at follow-up