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
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.
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.
Exclusion Criteria:
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
Also known as: CONNECT
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
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
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.
| Milestone | Device Treatment |
|---|---|
| Started | 88 |
| Completed | 84 |
| Not completed | 4 |
| Withdrew: Screen fails | 4 |
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.
| participants | Enrolled/Primary Cohort |
|---|---|
| Major Adverse Events | 4 |
Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.
| participants | Enrolled/Primary Cohort |
|---|---|
| CTO Crossing Success Using the Wildcat | 75 |
Collected over 30-Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled/Primary Cohort | — | 4/84 (4.8%) | 0/84 (0%) |
| Event | Enrolled/Primary Cohort |
|---|---|
| Clinically Significant PerforationVascular disorders | 4/84 |
| Major Adverse Event - DeathGeneral disorders | 0/84 |
| Major Adverse Event - Unplanned Major AmputationVascular disorders | 0/84 |
| Major Adverse Event - Emergent Target Vessel RevascularizationVascular disorders | 0/84 |
| Clinically Significant EmbolizationVascular disorders | 0/84 |
| Grade C DissectionVascular disorders | 0/84 |
| Age, Categorical(Participants) | Enrolled/Primary Cohort |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 62 |
| Age, Continuous(years) | Enrolled/Primary Cohort |
|---|---|
| Mean | 69.5 ± 11.1 |
| Sex: Female, Male(Participants) | Enrolled/Primary Cohort |
|---|---|
| Female | 41 |
| Male | 47 |
| Region of Enrollment(participants) | Enrolled/Primary Cohort |
|---|---|
| United States | 88 |
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Avinger, Inc.