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Clinical Trials/NL-OMON53557
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Zuyderland Medisch Centrum

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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