Total Atherosclerotic Occlusion of Femoral Artery
Conditions
Keywords
Chronic Total Occlusion, Optimal Coherence Tomography, Lumivascular
Brief summary
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
Detailed description
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.
Interventions
DEVICECTO crossing in femoropopliteal arteries CONNECT II
CTO crossing in femoropopliteal arteries using the Ocelot System
Sponsors
Avinger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is willing and able to provide informed consent * Patient is willing and able to comply with the study protocol * Patient is \> 18 years old * Patient has peripheral arterial disease requiring revascularization as evidenced by CTA, MRA or angiography * Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate * Target vessel is ≥ 3.0 mm in diameter * Patient has Rutherford Classification of 2-5 * Lesion is recalcitrant to guidewire crossing
Exclusion criteria
* Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated * Patient has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications * Patient is pregnant or lactating * Patient has a co-existing disease or medical condition contraindicating percutaneous intervention * Target vessel is severely calcified as evidenced by angiography * Target lesion is in a bypass graft * Target lesion is in a stent (i.e., in-stent restenosis) * Patient has had a procedure on the target limb within 7 days * Patient has had a procedure on the target limb within the past 30 days and is unstable * Patient has a planned surgical or interventional procedure within 30 days after the study procedure * Patient is simultaneously participating in an investigational device study for treatment of peripheral vascular disease * Patient has a planned amputation of the target limb * Patient has a history of bleeding diathesis, coagulopathy or will refuse blood transfusion in cases of emergency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | Day 30 | 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. |
| Primary Efficacy Endpoint | Day 0 | Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance | Day 0 | 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. |
| Procedural Time | Day 0 | Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO |
| Fluoroscopic Time | Day 0 | Total time fluoroscopy was used during the procedure. |
| Procedural Success | Day 0 | 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. |
| Use of Assist Devices | Day 0 | Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices. |
| Contrast/Flush Volumes | Day 0 | Contrast and flush volumes are presented |
| CTO Crossing Time | Day 0 | Time required to cross the CTO during the procedure. |
| Technical Success | Day 0 | Successful delivery, crossing and retrieval of the investigational device without the use of an assist device. |
Countries
Germany, Italy, United States
Participant flow
Recruitment details
Patients with CTO were approached to consider joining the study.
Participants by arm
| Arm | Count |
|---|---|
| Ocelot System CTO crossing in femoropopliteal arteries using the Ocelot System | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Ocelot System |
|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 9.3 |
| Ankle-Brachial Index ABI < 0.4: Chronic Limb Ischemia | 8 Participants |
| Ankle-Brachial Index ABI < 0.6: Intermittent Claudication | 38 Participants |
| Ankle-Brachial Index ABI ≥ 0.95: Normal | 5 Participants |
| Ankle-Brachial Index ABI < 0.95: Peripheral Vascular Disease | 47 Participants |
| Ankle-Brachial Index ABI >1.3: Non-Compressible Vessels | 0 Participants |
| Body Mass Index | 28.7 kg/m^2 STANDARD_DEVIATION 6.1 |
| Race/Ethnicity, Customized African American | 18 Participants |
| Race/Ethnicity, Customized American Indian | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 64 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Region of Enrollment Germany | 13 participants |
| Region of Enrollment Italy | 6 participants |
| Region of Enrollment United States | 81 participants |
| Rutherford 0 - Asymptomatic | 0 Participants |
| Rutherford 1 - Mild Claudication | 0 Participants |
| Rutherford 2 - Moderate Claudication | 13 Participants |
| Rutherford 3 - Severe Claudication | 61 Participants |
| Rutherford 4 - Ischemic Rest Pain | 20 Participants |
| Rutherford 5 - Minor Tissue Loss | 6 Participants |
| Rutherford 6 - Major Tissue Loss | 0 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 25 / 100 |
| serious Total, serious adverse events | 26 / 100 |
Outcome results
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.
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ocelot System | Primary Efficacy Endpoint | 97 Participants |
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.
Time frame: Day 30
Population: Two subjects withdrew prior to 30-day follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocelot System | Primary Safety Endpoint | 2 Percent of participants |
Secondary
Contrast/Flush Volumes
Contrast and flush volumes are presented
Time frame: Day 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ocelot System | Contrast/Flush Volumes | Flush Volume (through Ocelot for visualization only) | 33.1 ml | Standard Deviation 57.9 |
| Ocelot System | Contrast/Flush Volumes | Contrast Volume (used for entire procedure) | 223.0 ml | Standard Deviation 144.7 |
| Ocelot System | Contrast/Flush Volumes | Contrast Volume (procedure start through CTO crossing) | 124.5 ml | Standard Deviation 100.3 |
Secondary
CTO Crossing Time
Time required to cross the CTO during the procedure.
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocelot System | CTO Crossing Time | 32.9 minutes | Standard Deviation 42.9 |
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.
Time frame: Day 0
Population: '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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ocelot System | Device Performance | Catheter Performance Evaluation: Tip Deflection | 5 - Excellent | 56 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Tip Deflection | 4 - Good | 25 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Tip Deflection | 3 - Acceptable | 18 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Tip Deflection | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Tip Deflection | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Ability to stay in true lumen | 1 - Unacceptable | 1 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Visibility of radiopaque marker | 5 - Excellent | 82 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of side branches | 5 - Excellent | 60 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of side branches | 4 - Good | 24 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Introduction into sheath | 5 - Excellent | 87 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Introduction into sheath | 4 - Good | 13 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Introduction into sheath | 3 - Acceptable | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Introduction into sheath | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Introduction into sheath | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter trackability | 5 - Excellent | 76 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter trackability | 4 - Good | 21 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter trackability | 3 - Acceptable | 3 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter trackability | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter trackability | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter pushability | 5 - Excellent | 62 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter pushability | 4 - Good | 31 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter pushability | 3 - Acceptable | 6 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter pushability | 2 - Poor | 1 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter pushability | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Ability to stay in true lumen | 5 - Excellent | 65 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Ability to stay in true lumen | 4 - Good | 22 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Ability to stay in true lumen | 3 - Acceptable | 10 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Ability to stay in true lumen | 2 - Poor | 2 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Visibility of radiopaque marker | 4 - Good | 13 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Visibility of radiopaque marker | 3 - Acceptable | 5 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Visibility of radiopaque marker | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Visibility of radiopaque marker | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter tip visibility | 5 - Excellent | 84 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter tip visibility | 4 - Good | 13 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter tip visibility | 3 - Acceptable | 3 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter tip visibility | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | Catheter Performance Evaluation: Catheter tip visibility | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Clarity of images | 5 - Excellent | 63 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Clarity of images | 4 - Good | 31 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Clarity of images | 3 - Acceptable | 5 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Clarity of images | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Clarity of images | 1 - Unacceptable | 1 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of layered structures | 5 - Excellent | 65 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of layered structures | 4 - Good | 22 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of layered structures | 3 - Acceptable | 11 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of layered structures | 2 - Poor | 1 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of layered structures | 1 - Unacceptable | 1 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of non-layered structures | 5 - Excellent | 63 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of non-layered structures | 4 - Good | 20 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of non-layered structures | 3 - Acceptable | 14 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of non-layered structures | 2 - Poor | 2 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of non-layered structures | 1 - Unacceptable | 1 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of side branches | 3 - Acceptable | 7 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of side branches | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Visualization of side branches | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Flush adequately displaces blood for visualization | 5 - Excellent | 70 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Flush adequately displaces blood for visualization | 4 - Good | 28 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Flush adequately displaces blood for visualization | 3 - Acceptable | 2 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Flush adequately displaces blood for visualization | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Flush adequately displaces blood for visualization | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability to orient using the middle marker | 5 - Excellent | 65 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability to orient using the middle marker | 4 - Good | 25 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability to orient using the middle marker | 3 - Acceptable | 10 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability to orient using the middle marker | 2 - Poor | 0 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability to orient using the middle marker | 1 - Unacceptable | 0 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation | 5 - Excellent | 70 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation | 4 - Good | 22 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation | 3 - Acceptable | 7 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation | 2 - Poor | 1 Participants |
| Ocelot System | Device Performance | OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation | 1 - Unacceptable | 0 Participants |
Secondary
Fluoroscopic Time
Total time fluoroscopy was used during the procedure.
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocelot System | Fluoroscopic Time | 38.6 minutes | Standard Deviation 29.1 |
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.
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ocelot System | Procedural Success | 95 Participants |
Secondary
Procedural Time
Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocelot System | Procedural Time | 107.3 minutes | Standard Deviation 57.5 |
Secondary
Technical Success
Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ocelot System | Technical Success | 72 Participants |
Secondary
Use of Assist Devices
Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices.
Time frame: Day 0
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ocelot System | Use of Assist Devices | CTO Crossing Time: Ocelot Alone | 16.8 minutes | Standard Deviation 18.4 |
| Ocelot System | Use of Assist Devices | CTO Crossing Time: Ocelot and assist devices | 79.1 minutes | Standard Deviation 58.1 |