Clinical trial NCT02734095: Determining Predictors of Restenosis in Femoropopliteal Lesions
Official title: Determining Predictors of Restenosis. Intravascular Ultrasound in the Treatment of Femoropopliteal Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plaque Burden Measure
timeFrame: intraoperative
measure: Reference Lumen Measure
timeFrame: intraoperative
measure: Reference Diameter Measure
timeFrame: intraoperative
measure: Stent/reference Diameter Ratio Measure
timeFrame: intraoperative
measure: Stent Expansion Ratio Measure
timeFrame: intraoperative
measure: Radial Stent Symmetry Index Measure
timeFrame: intraoperative
measure: Axial Stent Symmetry Index Measure
timeFrame: intraoperative
measure: In Stent Restenosis
timeFrame: 12 months (±30 days)
Secondary outcomes:
measure: Technical success
timeFrame: intraoperative
measure: Freedom of reintervention at each follow-up
timeFrame: Baseline
measure: Freedom of reintervention at each follow-up
timeFrame: 1 month (± 7 days)
measure: Freedom of reintervention at each follow-up
timeFrame: 3 months (±30 days)
measure: Freedom of reintervention at each follow-up
timeFrame: 6 months (±30 days)
measure: Freedom of reintervention at each follow-up
timeFrame: 12 months (±30 days)
measure: Limb-salvage rate
timeFrame: Baseline
measure: Limb-salvage rate
timeFrame: 1 month (± 7 days)
measure: Limb-salvage rate
timeFrame: 3 months (±30 days)
measure: Limb-salvage rate
timeFrame: 6 months (±30 days)
measure: Limb-salvage rate
timeFrame: 12 months (±30 days)
measure: Serious adverse events
timeFrame: Baseline
measure: Serious adverse events
timeFrame: 1 month (± 7 days)
measure: Serious adverse events
timeFrame: 3 months (±30 days)
measure: Serious adverse events
timeFrame: 6 months (±30 days)
measure: Serious adverse events
timeFrame: 12 months (±30 days)
measure: Clinical success at follow-up
timeFrame: Baseline
measure: Clinical success at follow-up
timeFrame: 1 month (± 7 days)
measure: Clinical success at follow-up
timeFrame: 3 months (±30 days)
measure: Clinical success at follow-up
timeFrame: 6 months (±30 days)
measure: Clinical success at follow-up
timeFrame: 12 months (±30 days)
Other outcomes:
Locations:
Study officials:
affiliation: University of Campinas, Brazil
name: Martin A Geiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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