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CompletedNCT01174784CONNECTUpdated Jul 17, 2020Results posted

Chronic Total Occlusion Crossing With the Wildcat Catheter

An interventional study of Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer in Peripheral Arterial Disease, sponsored by Avinger, Inc.. Completed at 15 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-07-17.

Sponsored by Avinger, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Chronic Total Occlusions
  • Superficial Femoral Artery
  • Popliteal Artery
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • 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

Interventions

  • DeviceChronic 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

    Also known as: CONNECT

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Index through 30-Day Follow-Up

  2. 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.

    Time frame: Index through 30-Day Follow-Up

06

Results

Posted Sep 27, 2013

Participant flow

Subjects were recruited/enrolled in the study starting on August 31, 2010. 88 subjects were enrolled and exited the study by April 11, 2011. Angiographic review after the case revealed that 4 of the 88 cases did not meet the inclusion criteria and were considered screen failures per the protocol and excluded from the efficacy analyses.

Participant flow — Overall Study
MilestoneDevice Treatment
Started88
Completed84
Not completed4
Withdrew: Screen fails4

Outcome measures

PrimaryMajor 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.

Time frame:
Index through 30-Day Follow-Up
Reported as:
Number · participants
Major Adverse Events
participantsEnrolled/Primary Cohort
Major Adverse Events4
PrimaryCTO 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.

Time frame:
Index through 30-Day Follow-Up
Reported as:
Number · participants
CTO Crossing Success Using the Wildcat
participantsEnrolled/Primary Cohort
CTO Crossing Success Using the Wildcat75

Adverse events

Collected over 30-Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enrolled/Primary Cohort—4/84 (4.8%)0/84 (0%)
Most frequent serious events
Most frequent serious events
EventEnrolled/Primary Cohort
Clinically Significant PerforationVascular disorders4/84
Major Adverse Event - DeathGeneral disorders0/84
Major Adverse Event - Unplanned Major AmputationVascular disorders0/84
Major Adverse Event - Emergent Target Vessel RevascularizationVascular disorders0/84
Clinically Significant EmbolizationVascular disorders0/84
Grade C DissectionVascular disorders0/84

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Enrolled/Primary Cohort
<=18 years0
Between 18 and 65 years26
>=65 years62
Age, Continuous
Age, Continuous(years)Enrolled/Primary Cohort
Mean69.5 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Enrolled/Primary Cohort
Female41
Male47
Region of Enrollment
Region of Enrollment(participants)Enrolled/Primary Cohort
United States88
07

Study locations

15 sites
  • Birmingham Heart Clinic
    Birmingham, Alabama 35235, United States
  • Arizona Regional / Adventis
    Mesa, Arizona 85206, United States
  • Phoenix Heart Center
    Phoenix, Arizona 85006, United States
  • Sutter Memorial
    Sacramento, California 95619, United States
  • Sharp Memorial
    San Diego, California 92123, United States
  • Coastal Vascular
    Pensacola, Florida 32501, United States
  • Emory University Hospital
    Atlanta, Georgia 30308, United States
  • Detroit Medical Center
    Detroit, Michigan 48201, United States
  • St. John Hospital and Medical Center
    Detroit, Michigan 48236, United States
  • Central Michigan Community Hospital
    Mount Pleasant, Michigan 48858, United States
  • St. Louis University
    Saint Louis, Missouri 63110, United States
  • Jobst Vascular Center
    Toledo, Ohio 43606, United States
  • Austin Heart
    Austin, Texas 78756, United States
  • Cardiology Care Consultants
    El Paso, Texas 79902, United States
  • El Paso Cardiology Associates
    El Paso, Texas 79902, United States
08

Registry details

Key details

Study ID
NCT01174784
Lead sponsor
Avinger, Inc.
Responsible party
Sponsor
First posted
Aug 4, 2010
Start date
Aug 2010
Primary completion
Apr 2011
Completion
Jun 2011
Results posted
Sep 27, 2013
Last update
Jul 17, 2020

Study contacts

Tom Davis, MD
principal investigator · St. John Hospital
Laiq Raja, MD
principal investigator · El Paso Cardiology Associates

Oversight

Data monitoring committee
No
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