Chronic Total Occlusion Crossing With the Wildcat Catheter (CONNECT)

A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer

Detailed Description

Patients with a CTO, defined as 99% to 100% stenosis of a peripheral artery, will be approached for enrollment in the study. Following providing informed consent, the CTO will be addressed by the Wildcat catheter, which will provide a route for the advancement of guidewires and other tools beyond the CTO. Data will be collected to assess the safety efficacy of use of the device during the procedure and up to 30 days post-procedure.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; The Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device.	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 Names: CONNECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events	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.	Index through 30-Day Follow-Up
CTO Crossing Success Using the Wildcat	Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.	Index through 30-Day Follow-Up

Collaborators and Investigators

• Sponsor: Avinger, Inc.
• Investigators: Principal Investigator: Tom Davis, MD, St. John Hospital; Principal Investigator: Laiq Raja, MD, El Paso Cardiology Associates

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: August 2, 2010
• First Submitted That Met QC Criteria: August 3, 2010
• First Posted (ESTIMATE): August 4, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Superficial Femoral Artery; Popliteal Artery; Chronic Total Occlusions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: AVI CTO 10001