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Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
The purpose of this clinical study is to evaluate the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing chronic total occlusions (CTOs) in femoropopliteal arteries. The Ocelot Catheter is a minimally invasive percutaneous device that is designed to traverse arterial occlusions through the use of spiral wedges contained in the distal tip of the device. The device is also equipped with an OCT (optical coherence tomography) imaging fiber that provides directional orientation and an intravascular view of the vessel wall and target lesion. The Ocelot Catheter is used in conjunction with standard endovascular devices and as an adjunct to fluoroscopic guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocelot System | Experimental | CTO crossing in femoropopliteal arteries using the Ocelot System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTO crossing in femoropopliteal arteries CONNECT II | Device | CTO crossing in femoropopliteal arteries using the Ocelot System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography. | Day 30 |
| Primary Efficacy Endpoint | Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections. | Day 0 |
| Technical Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Selmon, MD | Austin Heart Hospital | Principal Investigator |
| Arne Schwindt, MD | Muenster Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States | ||
| Sutter Memorial |
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| Label | URL |
|---|---|
| Avinger web site | View source |
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Patients with CTO were approached to consider joining the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocelot System | CTO crossing in femoropopliteal arteries using the Ocelot System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Successful delivery, crossing and retrieval of the investigational device without the use of an assist device. |
| Day 0 |
| Device Performance | Device performance as assessed by Investigator's input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO. | Day 0 |
| Procedural Time | Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO | Day 0 |
| Fluoroscopic Time | Total time fluoroscopy was used during the procedure. | Day 0 |
| CTO Crossing Time | Time required to cross the CTO during the procedure. | Day 0 |
| Use of Assist Devices | Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices. | Day 0 |
| Contrast/Flush Volumes | Contrast and flush volumes are presented | Day 0 |
| Sacramento |
| California |
| 95619 |
| United States |
| Cardiovascular Associates - Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| St. Joseph's Hospital | Fort Wayne | Indiana | 46802 | United States |
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| St. Dominic Hospital | Jackson | Mississippi | 39216 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Jobst Vascular Center | Toledo | Ohio | 43606 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| El Paso Cardiology Associates | El Paso | Texas | 79902 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Leipzig Hospital | Leipzig | 04289 | Germany |
| Muenster Hospital | Münster | 48145 | Germany |
| Mirano Hospital | Mirano | 30035 | Italy |
| COMPLETED |
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| NOT COMPLETED |
|
All enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocelot System | CTO crossing in femoropopliteal arteries using the Ocelot System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Data unknown for 12 subjects. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Rutherford | Count of Participants | Participants |
| ||||||||||||||||||
| Ankle-Brachial Index | Data not obtained for 2 subjects. | Count of Participants | Participants |
| |||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Primary Safety Endpoint | No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography. | Two subjects withdrew prior to 30-day follow-up. | Posted | Number | 95% Confidence Interval | Percent of participants | Day 30 |
|
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| |||||||||||||||||||||||||
| Primary | Primary Efficacy Endpoint | Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography. | Posted | Count of Participants | Participants | Day 0 |
|
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| |||||||||||||||||||||||||||
| Secondary | Procedural Success | Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections. | Posted | Count of Participants | Participants | Day 0 |
|
| ||||||||||||||||||||||||||||
| Secondary | Technical Success | Successful delivery, crossing and retrieval of the investigational device without the use of an assist device. | Posted | Count of Participants | Participants | Day 0 |
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| |||||||||||||||||||||||||||
| Secondary | Device Performance | Device performance as assessed by Investigator's input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO. | 'Catheter Performance Evaluation: Tip Deflection': Data was missing for one subject for this question. 'OCT Performance Evaluation: Visualization of side branches': N/A in 9 subjects who did not have side branches visualized. | Posted | Count of Participants | Participants | Day 0 |
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| Secondary | Procedural Time | Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO | Posted | Mean | Standard Deviation | minutes | Day 0 |
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| Secondary | Fluoroscopic Time | Total time fluoroscopy was used during the procedure. | Posted | Mean | Standard Deviation | minutes | Day 0 |
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| ||||||||||||||||||||||||||
| Secondary | CTO Crossing Time | Time required to cross the CTO during the procedure. | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
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| ||||||||||||||||||||||||||
| Secondary | Use of Assist Devices | Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices. | Seventy-two participants in the 'CTO Crossing Time: Ocelot Alone'. Twenty-five participants in the 'CTO Crossing Time: Ocelot and assist devices'. Three subjects who did not have their CTO successfully crossed were excluded from calculation. | Posted | Mean | Standard Deviation | minutes | Day 0 |
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| Secondary | Contrast/Flush Volumes | Contrast and flush volumes are presented | Posted | Mean | Standard Deviation | ml | Day 0 |
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Day 0 through Day 30
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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 | Ocelot System | CTO crossing in femoropopliteal arteries using the Ocelot System | 0 | 100 | 26 | 100 | 25 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AV Fistula | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vessel Dissection, Grade C or greater | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vessel Dissection, Grade A or B | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Bruising or hemorrhage at procedural access site | Vascular disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombosis | Vascular disorders | Systematic Assessment |
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| Pain, new or worsening | Vascular disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
| ||
| Pseudoaneurysm | Vascular disorders | Systematic Assessment |
| ||
| Bleeding (other than access site) | Vascular disorders | Systematic Assessment |
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| Hypotension, sustained | Vascular disorders | Systematic Assessment |
| ||
| Perforation requiring intervention | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Shortness of breath | Cardiac disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Perforation, not requiring intervention | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Acute COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| limb ischemia | Vascular disorders | Systematic Assessment |
| ||
| Aneurysm | Vascular disorders | Systematic Assessment |
| ||
| Embolism | Vascular disorders | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Allergic reaction to contrast medium | Immune system disorders | Systematic Assessment |
| ||
| Altered mental state | Psychiatric disorders | Systematic Assessment |
| ||
| Leg ulcerations | Vascular disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Intractable nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lethargy | General disorders | Systematic Assessment |
| ||
| Uncontrolled hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising or hemorrhage at procedural access site | Vascular disorders | Systematic Assessment |
| ||
| Swelling | Vascular disorders | Systematic Assessment |
| ||
| Bleeding, other than access site | Vascular disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Dysphagia | Nervous system disorders | Systematic Assessment |
| ||
| Nausea/Vomiting | General disorders | Systematic Assessment |
| ||
| Pain, new or worsening | General disorders | Systematic Assessment |
| ||
| Perforation not requiring intervention | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pseudoaneurysm | Vascular disorders | Systematic Assessment |
| ||
| Vessel dissection, Grade A or B | Vascular disorders | Systematic Assessment |
| ||
| Vessel dissection, Grade C or greater | Vascular disorders | Systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| AV fistula | Vascular disorders | Systematic Assessment |
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Following the earliest of (a)publication of results, (b)receipt of notice stating that Study has been terminated or (c)18 months after completion or termination, Institution/Investigator (IN) shall have right to publish information & data collected or produced, provided that drafts are provided to Sponsor (SP) at least 60 days prior to the first submission. SP shall comment within 45 days. IN shall delay publication/presentation to enable SP to secure patent or other proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Selmon, MD | Austin Heart | 512-788-2692 | matthew.selmon@hcahealthcare.com |
| African American |
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| Hispanic/Latino |
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| Asian |
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| American Indian |
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| Native Hawaiian or Pacific Islander |
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| Other |
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| Italy |
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| 2 - Moderate Claudication |
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| 3 - Severe Claudication |
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| 4 - Ischemic Rest Pain |
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| 5 - Minor Tissue Loss |
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| 6 - Major Tissue Loss |
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| ABI ≥ 0.95: Normal |
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| ABI < 0.95: Peripheral Vascular Disease |
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| ABI < 0.6: Intermittent Claudication |
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| ABI < 0.4: Chronic Limb Ischemia |
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| Categories |
|---|
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| Title |
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| Denominators |
|---|
| Categories |
|---|
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| Contrast Volume (used for entire procedure) |
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| Contrast Volume (procedure start through CTO crossing) |
|
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| 2 - Poor |
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| 1 - Unacceptable |
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| 2 - Poor |
|
| 1 - Unacceptable |
|
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| 2 - Poor |
|
| 1 - Unacceptable |
|
|
| 2 - Poor |
|
| 1 - Unacceptable |
|
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| 2 - Poor |
|
| 1 - Unacceptable |
|
|
| 2 - Poor |
|
| 1 - Unacceptable |
|
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| 2 - Poor |
|
| 1 - Unacceptable |
|
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| 2 - Poor |
|
| 1 - Unacceptable |
|
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| 2 - Poor |
|
| 1 - Unacceptable |
|
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| 2 - Poor |
|
| 1 - Unacceptable |
|
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| 2 - Poor |
|
| 1 - Unacceptable |
|
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| 2 - Poor |
|
| 1 - Unacceptable |
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| 2 - Poor |
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| 1 - Unacceptable |
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