N/A
Completed N=88
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
| Outcome | Result | p-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.
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.