NCT02387658

Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: North Texas Veterans Healthcare System · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. To perform an observational analysis to determine if mean translesional gradient measurements (TLG) are associated with differences in clinical outcomes in patients with femoropopliteal arterial disease and claudication. 2. Hypothesis: Patients stratified by a residual translesional gradient \</= 11 mmHg after peripheral revascularization or angiography alone will have better clinical outcomes than patients with TLG \> 11 mmHg as assessed by six minute walk (6MW), walking impairment questionnaire scores (WIQ), ankle brachial index and need for repeat procedure at 6 months.

Detailed description

The role of measuring translesional pressure gradients(TLG) in peripheral arterial disease lesions below the iliac artery is unclear. In a previous study the investigators demonstrated that a pressure wire can be effectively used to measure gradients in the femoropopliteal (FP) arterial bed showing good correlation between TLGs recorded with exercise ankle brachial index and walking impairment scores. However there is a no evidence that effectively modifying the gradient or having a high residual gradient after revascularization or just with medical therapy correlates with worse clinical outcomes. This is a prospective, single center, observational clinical study to evaluate whether measurement of mean residual TLG at the time of angiography and/or immediately after endovascular revascularization are associated with clinically important outcomes in patients with claudication symptoms. Prior to angiography they will be asked to complete an ankle brachial index evaluation, baseline six minute walk test and walking impairment questionnaire. Arterial access should be obtained in the contralateral common femoral artery to the symptomatic limb if feasible. Angiographic images are to be obtained, interpreted and clinical decisions regarding endovascular treatment are to be made per treating physician's discretion prior to obtaining translesional pressure gradients. In patients whose angiogram does not meet exclusion criteria and do not have a chronic total occlusion (CTO) a baseline TLG will be obtained. A 0.014" pressure wire/catheter to measure pressure will be inserted. After baseline calibration in the superficial femoral artery, the wire will be inserted past the narrowest lesion into the popliteal vessel. Intra-arterial adenosine 100-200 mcg will be given for hyperemia and measurements are to be recorded. If an intervention is planned, repeat measurements are to be obtained at the end of the procedure. If no intervention is planned this will be the residual or final TLG recorded. If baseline measurement are unable to obtained due to a CTO then only a post intervention residual TLG will be obtained and included in analysis. The operator will be blinded to the pre and post TLG measurements by turning the display monitor away from the procedure table and towards the recorder situated in the procedure room when measurements are being obtained. Patients will follow up within two weeks post angiography for routine scheduled follow up and will obtain repeat ABI, WIQ, and six minute walk if they underwent revascularization. Treating physicians and study coordinators collecting these test measurements will be blinded to TLG measurements but not to angiography and treatment. Patients will again be evaluated at 6 months follow up with repeat ABI, WIQ and six minute walk.

Conditions

• Peripheral Arterial Disease
• Claudication

Interventions

Type	Name	Description
PROCEDURE	translesional gradient measurement	Patients will be stratified into two groups based on the final mean translesional pressure gradient obtained in the femoropopliteal arterial bed after revascularization or just after angiography if no revascularization is done.

Timeline

• Start date: 2015-02-06
• Primary completion: 2016-07-13
• Completion: 2016-07-13
• First posted: 2015-03-13
• Last updated: 2018-09-12

Locations

1 site across 1 country: United States