Peripheral Arterial Disease
Conditions
Keywords
Chronic Total Occlusions, Superficial Femoral Artery, Popliteal Artery
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.
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.
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
Sponsors
Avinger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | 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. |
| CTO Crossing Success Using the Wildcat | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled/Primary Cohort Subjects with a CTO upon presentation to the surgical unit. | 88 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen fails | 4 |
Baseline characteristics
| Characteristic | Enrolled/Primary Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 62 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 69.5 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 88 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 84 |
| serious Total, serious adverse events | 4 / 84 |
Outcome results
Primary
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
Population: Patients treated with Wildcat post guidewire failure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrolled/Primary Cohort | CTO Crossing Success Using the Wildcat | 75 participants |
Primary
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
Population: Patients treated with Wildcat post guidewire failure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrolled/Primary Cohort | Major Adverse Events | 4 participants |