NL-OMON53557
Recruiting
Not Applicable
Fractional Flow Reserve in Critical Limb Ischemia Patients - FFR-guided PTA
Zuyderland Medisch Centrum0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zuyderland Medisch Centrum
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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