Fractional Flow Reserve in Critical Limb Ischemia Patients
- Conditions
- 'peripheral arterial disease' en 'intermittent claudication'10003216
- Registration Number
- NL-OMON53557
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
In order to be eligible to participate in this study, a subject must meet all
the following criteria:
- Patients of any race or sex, and any age above 18 years, who electively
undergo a single-lesion PTA of the anterior or posterior tibial artery
- The lesion is no longer than 3 cm
- Critical limb ischemia defined as Fontaine class 3 or 4
- Patients provide informed consent
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Acute limb ischemia
- Complete atrioventricular node block
- Revascularization involving the same limb within 30 days prior to the index
procedure
- Known allergy to iodine contrast
- Previous implanted stent at the index site
- Previous major amputation in the same limb as the index site
- Pregnant patients
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main question to be answered is: *Is FFR safe to use in PTA procedures in<br /><br>patients with critical limb ischemia in below-the-knee arteries in the<br /><br>Zuyderland Medical Center, and what is the effect of FFR on intraoperative<br /><br>decision-making?*</p><br>
- Secondary Outcome Measures
Name Time Method