Chronic Total Occlusion Crossing With the Wildcat Catheter
NCT ID: NCT01174784
Last Updated: 2020-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2010-08-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
The Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device.
Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer
A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
Interventions
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Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer
A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is willing and able to comply with the study protocol.
3. Patient is \> 18 years old.
4. Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
5. Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate.
6. Target femoropopliteal vessel is ≥ 3.0 mm in diameter.
7. Patient has Rutherford Classification of 2-5.
Exclusion Criteria
2. Patient has a known sensitivity or allergy to anti-platelet medications.
3. Patient is pregnant or lactating.
4. Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
5. Target vessel is severely calcified as evidenced by angiography.
6. Target lesion is in a bypass graft.
7. Target lesion is in a stent (i.e., in-stent restenosis).
8. Patient has had a procedure on the target limb within 7 days.
9. Patient has had a procedure on the target limb within the past 30 days and is unstable.
10. Patient is simultaneously participating in an investigational device or drug study.
11. Patient has a planned surgical or interventional procedure within 30 days after the study procedure.
19 Years
ALL
No
Sponsors
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Avinger, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Davis, MD
Role: PRINCIPAL_INVESTIGATOR
St. John Hospital
Laiq Raja, MD
Role: PRINCIPAL_INVESTIGATOR
El Paso Cardiology Associates
Locations
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Birmingham Heart Clinic
Birmingham, Alabama, United States
Arizona Regional / Adventis
Mesa, Arizona, United States
Phoenix Heart Center
Phoenix, Arizona, United States
Sutter Memorial
Sacramento, California, United States
Sharp Memorial
San Diego, California, United States
Coastal Vascular
Pensacola, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Detroit Medical Center
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Central Michigan Community Hospital
Mount Pleasant, Michigan, United States
St. Louis University
St Louis, Missouri, United States
Jobst Vascular Center
Toledo, Ohio, United States
Austin Heart
Austin, Texas, United States
Cardiology Care Consultants
El Paso, Texas, United States
El Paso Cardiology Associates
El Paso, Texas, United States
Countries
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Other Identifiers
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AVI CTO 10001
Identifier Type: -
Identifier Source: org_study_id
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