Total Atherosclerotic Occlusion of Femoral Artery Clinical Trial
— CONNECTIIOfficial title:
A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
| NCT number | NCT01537302 |
| Other study ID # | AVI OCT 10005 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2012 |
| Est. completion date | June 2012 |
| Verified date | March 2021 |
| Source | Avinger, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Leipzig Hospital | Leipzig | |
| Germany | Muenster Hospital | Muenster | |
| Italy | Mirano Hospital | Mirano | |
| United States | Austin Heart | Austin | Texas |
| United States | Deborah Heart and Lung Center | Browns Mills | New Jersey |
| United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
| United States | Detroit Medical Center | Detroit | Michigan |
| United States | St. John Hospital and Medical Center | Detroit | Michigan |
| United States | El Paso Cardiology Associates | El Paso | Texas |
| United States | Cardiovascular Associates - Alexian Brothers Medical Center | Elk Grove Village | Illinois |
| United States | St. Joseph's Hospital | Fort Wayne | Indiana |
| United States | St. Dominic Hospital | Jackson | Mississippi |
| United States | Arkansas Heart Hospital | Little Rock | Arkansas |
| United States | Columbia University Medical Center | New York | New York |
| United States | The Heart Hospital Baylor Plano | Plano | Texas |
| United States | Sutter Memorial | Sacramento | California |
| United States | Jobst Vascular Center | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Avinger, Inc. |
United States, Germany, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Day 30 | |
| 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. | Day 0 | |
| 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. | Day 0 | |
| Secondary | Technical Success | Successful delivery, crossing and retrieval of the investigational device without the use of an assist device. | Day 0 | |
| 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. | Day 0 | |
| Secondary | Procedural Time | Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO | Day 0 | |
| Secondary | Fluoroscopic Time | Total time fluoroscopy was used during the procedure. | Day 0 | |
| Secondary | CTO Crossing Time | Time required to cross the CTO during the procedure. | Day 0 | |
| Secondary | Use of Assist Devices | Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices. | Day 0 | |
| Secondary | Contrast/Flush Volumes | Contrast and flush volumes are presented | Day 0 |