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N/A Completed N=88 Treatment

Chronic Total Occlusion Crossing With the Wildcat Catheter

Source: ClinicalTrials.gov NCT01174784 ↗
Enrolled (actual)
88
Serious AEs
4.8%
Results posted
Sep 2013
Primary outcomePrimary: Major Adverse Events — 4 participants

Summary

This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated during the index procedure through 30-day follow-up.

Outcome Measures

OutcomeResultp-value
PRIMARY
Major Adverse Events
4
PRIMARY
CTO Crossing Success Using the Wildcat
75

Eligibility Criteria

Inclusion Criteria

  • Patient is willing and able to provide informed consent.
  • Patient is willing and able to comply with the study protocol.
  • Patient is > 18 years old.
  • Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
  • Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate.
  • Target femoropopliteal vessel is ≥ 3.0 mm in diameter.
  • Patient has Rutherford Classification of 2-5.

Exclusion Criteria

  • Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
  • Patient has a known sensitivity or allergy to anti-platelet medications.
  • Patient is pregnant or lactating.
  • Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
  • Target vessel is severely calcified as evidenced by angiography.
  • Target lesion is in a bypass graft.
  • Target lesion is in a stent (i.e., in-stent restenosis).
  • Patient has had a procedure on the target limb within 7 days.
  • Patient has had a procedure on the target limb within the past 30 days and is unstable.
  • Patient is simultaneously participating in an investigational device or drug study.
  • Patient has a planned surgical or interventional procedure within 30 days after the study procedure.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01174784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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