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Clinical Trials/NL-OMON51664
NL-OMON51664
Not yet recruiting
Not Applicable

Optical Coherence Tomography (OCT) guided Percutaneous Transluminal Angiography (PTA) in lesions below the knee: a proof of concept study - OCT-guided PTA concept

Zuyderland Medisch Centrum0 sites20 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Zuyderland Medisch Centrum
Enrollment
20
Status
Not yet 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

  • \- 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
  • \- Kidney function with eGFR \> 30 ml/min, allowing contrast iodine to be used
  • unless patient is dependent on dialysis without residual diuresis

Exclusion Criteria

  • \- Acute limb ischemia
  • \- 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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