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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | The Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer | Device | A Non-Randomized Study of the Avinger Wildcatâ„¢ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Davis, MD | St. John Hospital | Principal Investigator |
| Laiq Raja, MD | El Paso Cardiology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Heart Clinic | Birmingham | Alabama | 35235 | United States | ||
| Arizona Regional / Adventis |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Device Treatment | This is a one-arm study. All subjects will have a CTO addressed by the Wildcat crossing device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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 | St 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled/Primary Cohort | Subjects with a CTO upon presentation to the surgical unit. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients treated with Wildcat post guidewire failure. | Posted | Number | participants | Index through 30-Day Follow-Up |
|
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| ||||||||||||||||||||||||||
| 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. | Patients treated with Wildcat post guidewire failure. | Posted | Number | participants | Index through 30-Day Follow-Up |
|
|
30-Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled/Primary Cohort | Patient with 99% to 100% stenosis of a peripheral artery. | 4 | 84 | 0 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Adverse Event - Death | General disorders | Systematic Assessment |
| ||
| Major Adverse Event - Unplanned Major Amputation | Vascular disorders | Systematic Assessment |
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| Major Adverse Event - Emergent Target Vessel Revascularization | Vascular disorders | Systematic Assessment |
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| Clinically Significant Perforation | Vascular disorders | Systematic Assessment |
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| Clinically Significant Embolization | Vascular disorders | Systematic Assessment |
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| Grade C Dissection | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Lawson, PhD | Avinger Inc. | 650.241.7900 | tlawson@avinger.com |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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