N/A N=88 Treatment

Chronic Total Occlusion Crossing With the Wildcat Catheter

Peripheral Arterial Disease

Bottom Line

View on ClinicalTrials.gov: NCT01174784 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Sep 2013

Primary outcome: Primary: Major Adverse Events — 4 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer (Device)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Avinger, Inc.
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Major Adverse Events	4	—
PRIMARY CTO Crossing Success Using the Wildcat	75	—

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.

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.