Clinical trial NCT03163199: TRanslesIonal Assessment of Gradients During Endovascular Therapy
Official title: TRanslesIonal Assessment of Gradients During Endovascular Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Fractional Flow Reserve
Hemodynamics
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with symptomatic peripheral arterial disease (critical limb ischemia or claudication)

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusions:

* 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

Primary outcomes:
measure: Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures
timeFrame: At baseline before catheter insertion, after the catheter is first inserted, to obtain initial blood flow reading, then immediately after the each attempt to clear the blockage, up to 5 times during the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Anand Prasad
role: PRINCIPAL_INVESTIGATOR
References: