Chronic Total Occlusion Crossing With the Wildcat Catheter (CONNECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avinger, Inc.
ClinicalTrials.gov Identifier:
NCT01174784
First received: August 2, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Peripheral Arterial Disease
Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs

Resource links provided by NLM:


Further study details as provided by Avinger, Inc.:

Primary Outcome Measures:
  • Major Adverse Events [ Time Frame: Index through 30-Day Follow-Up ] [ Designated as safety issue: Yes ]
    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.

  • CTO Crossing Success Using the Wildcat [ Time Frame: Index through 30-Day Follow-Up ] [ Designated as safety issue: No ]
    Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.


Enrollment: 88
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174784

Locations
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
Cardiology Care Consultants
El Paso, Texas, United States, 79902
El Paso Cardiology Associates
El Paso,, Texas, United States, 79902
Sponsors and Collaborators
Avinger, Inc.
Investigators
Principal Investigator: Tom Davis, MD St. John Hospital
Principal Investigator: Laiq Raja, MD El Paso Cardiology Associates
  More Information

No publications provided

Responsible Party: Avinger, Inc.
ClinicalTrials.gov Identifier: NCT01174784     History of Changes
Other Study ID Numbers: AVI CTO 10001
Study First Received: August 2, 2010
Results First Received: July 29, 2013
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 30, 2014