Chronic Total Occlusion Crossing With the Wildcat Catheter (CONNECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01174784
Recruitment Status : Completed
First Posted : August 4, 2010
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Information provided by (Responsible Party):
Avinger, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs
Study Start Date : August 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

Intervention Details:
  • 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
    Other Name: CONNECT

Primary Outcome Measures :
  1. Major Adverse Events [ Time Frame: Index through 30-Day Follow-Up ]
    The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.

  2. CTO Crossing Success Using the Wildcat [ Time Frame: Index through 30-Day Follow-Up ]
    Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is willing and able to provide informed consent.
  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:

  1. Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01174784

United States, Alabama
Birmingham Heart Clinic
Birmingham, Alabama, United States, 35235
United States, Arizona
Arizona Regional / Adventis
Mesa, Arizona, United States, 85206
Phoenix Heart Center
Phoenix, Arizona, United States, 85006
United States, California
Sutter Memorial
Sacramento, California, United States, 95619
Sharp Memorial
San Diego, California, United States, 92123
United States, Florida
Coastal Vascular
Pensacola, Florida, United States, 32501
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30308
United States, Michigan
St. John Hospital and Medical Center
Detoit, Michigan, United States, 48236
Detroit Medical Center
Detroit, Michigan, United States, 48201
Central Michigan Community Hospital
Mount Pleasant, Michigan, United States, 48858
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63110
United States, Ohio
Jobst Vascular Center
Toledo, Ohio, United States, 43606
United States, Texas
Austin Heart
Austin, Texas, United States, 78756
El Paso Cardiology Associates
El Paso,, Texas, United States, 79902
Cardiology Care Consultants
El Paso, Texas, United States, 79902
Sponsors and Collaborators
Avinger, Inc.
Principal Investigator: Tom Davis, MD St. John Hospital
Principal Investigator: Laiq Raja, MD El Paso Cardiology Associates

Responsible Party: Avinger, Inc. Identifier: NCT01174784     History of Changes
Other Study ID Numbers: AVI CTO 10001
First Posted: August 4, 2010    Key Record Dates
Results First Posted: September 27, 2013
Last Update Posted: September 27, 2013
Last Verified: July 2013

Keywords provided by Avinger, Inc.:
Chronic Total Occlusions
Superficial Femoral Artery
Popliteal Artery

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases