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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
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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
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

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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