Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient

Completed

Conditions studied: Peripheral Arterial Disease, Claudication

In brief

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.

Key facts

Study ID

NCT02387658

Run by

North Texas Veterans Healthcare System

People needed

25

Starts

2015-02-06

Expected to finish

2016-07-13

Last updated by the study team

2018-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• At least 18 years old
• Unilateral lower limb claudication Rutherford class 2-4
• Subjects must be able to complete screening six minute walk, walking impairment questionnaire, and baseline ankle brachial index
• Estimated survival ≥1 year in the judgment of the primary operator
• Documented symptomatic femoropopliteal (FP) atherosclerotic disease with at least moderate angiographic stenosis in the symptomatic lower extremity
• Subjects with multilevel disease can be screened and enrolled after treatment of other non FP PAD

You may not qualify if…

• Life expectancy less than 12 months or other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
• Severe Bilateral claudication
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
• Known hypersensitivity to adenosine or moderate to severe asthma
• Pregnancy
• Serum Creatinine >2.5
• Vascular graft, aneurysm or postsurgical stenosis of the target vessel
• Documented untreated severe iliac or below-the knee stenosis with < 2 vessel run-off in leg with femoropopliteal stenosis or untreated bilateral symptomatic peripheral arterial disease

Where it is running

• VA North Texas Health Care System — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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