TRanslesIonal Assessment of Gradients During Endovascular Therapy

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

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-12

Study Completion Date

2022-02-16

Brief Summary

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Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease.

Secondary objectives:

* Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following endovascular therapy
* Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in TLPGS
* Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and TLPGs
* Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional) and TLPGs

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Detailed Description

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There are a lack of tools available for the intraprocedural assessment of endovascular procedures for lower extremity peripheral arterial disease. The present study will use the NAVVUS RXi catheter to document changes in translesional hemodynamics obtained with and without hyperemia in patients undergoing directional atherectomy, angioplasty, and/or stenting of femoropopliteal and infrapoplieal lesions.

Conditions

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Peripheral Arterial Disease Fractional Flow Reserve Hemodynamics

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Translesional Hemodynamic Measurement

Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>18 y/o, undergoing clinically indicated endovascular therapy (balloon angioplasty, stenting, atherectomy or combination) for lower extremity peripheral artery disease (PAD) and claudication or critical limb ischemia (CLI). Rutherford Category 2-6.
* Includes iliac lesions, common femoral, superficial femoral artery, popliteal artery and tibial vessels
* A subject can be enrolled more than once (up to a maximum of two total times) for treatment of a staged lesion but must wait at least 6 weeks from the completion of the last study enrollment.

Exclusions:

* No pregnant females
* No vulnerable populations (dementia, prisoners, children)
* Baseline bradycardia (heart rate \<50 beats/min) or hypotension (systolic blood pressure \<90 mm Hg) will be excluded from receiving adenosine

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No