Total Atherosclerotic Occlusion of Femoral ArteryCONNECTIINCT01537302
Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
A study testing CTO crossing in femoropopliteal arteries CONNECT II in people with Total Atherosclerotic Occlusion of Femoral Artery, run by Avinger, Inc. at 17 sites in 3 countries.
Trial summary
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Atherosclerotic Occlusion of Femoral Artery
- What is being tested?
- CTO crossing in femoropopliteal arteries CONNECT II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Feb 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States14 sites
Austin Heart
Austin, Texas, 78756
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Detroit Medical Center
Detroit, Michigan, 48201
St. John Hospital and Medical Center
Detroit, Michigan, 48236
El Paso Cardiology Associates
El Paso, Texas, 79902
Cardiovascular Associates - Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
St. Joseph's Hospital
Fort Wayne, Indiana, 46802
St. Dominic Hospital
Jackson, Mississippi, 39216
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Columbia University Medical Center
New York, New York, 10032
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Sutter Memorial
Sacramento, California, 95619
Jobst Vascular Center
Toledo, Ohio, 43606
Germany2 sites
Leipzig Hospital
Leipzig, 04289
Muenster Hospital
Münster, 48145
About this study
Official title: A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
Read the 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.
- Being tested
- CTO crossing in femoropopliteal arteries CONNECT II
- Keywords
- Chronic Total Occlusion, Optimal Coherence Tomography, Lumivascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO crossing in femoropopliteal arteries CONNECT IIDevice
Also called Chronic TOtal OcclusioN CrossiNg with thE OCelot SysTem II, CONNECT II
CTO crossing in femoropopliteal arteries using the Ocelot System
| Study group | Role | What they receive |
|---|---|---|
| Ocelot System | Experimental | CTO crossing in femoropopliteal arteries using the Ocelot System Receives: Device: CTO crossing in femoropopliteal arteries CONNECT II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0
Secondary outcomes (8)
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.
Measured: Day 0
Technical Success
Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.
Measured: 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.
Measured: Day 0
Procedural Time
Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO
Measured: Day 0
Fluoroscopic Time
Total time fluoroscopy was used during the procedure.
Measured: Day 0
CTO Crossing Time
Time required to cross the CTO during the procedure.
Measured: Day 0
Use of Assist Devices
Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices.
Measured: Day 0
Contrast/Flush Volumes
Contrast and flush volumes are presented
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Atherosclerotic Occlusion of Femoral ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avinger, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Selmon, MD, Principal investigator, Austin Heart HospitalArne Schwindt, MD, Principal investigator, Muenster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537302
- Sponsor's protocol ID
- AVI OCT 10005
- Acronym
- CONNECTII
- Status last verified
- Mar 2021
- First submitted
- 15 Feb 2012
- Last updated
- 22 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
- ClinicalTrials.gov ID
- NCT01537302
- Acronym / sponsor ID
- CONNECTII / AVI OCT 10005
- Keywords
- Chronic Total Occlusion, Optimal Coherence Tomography, Lumivascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Avinger, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Posted 18 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocelot System | Experimental | Device: CTO crossing in femoropopliteal arteries CONNECT IICTO crossing in femoropopliteal arteries using the Ocelot System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTO crossing in femoropopliteal arteries CONNECT IIAlso: Chronic TOtal OcclusioN CrossiNg with thE OCelot SysTem II, CONNECT IICTO crossing in femoropopliteal arteries using the Ocelot System | Device | Ocelot System |
Primary outcome
Primary Safety Endpoint
Time frame: 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
Time frame: Day 0
Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.
8 secondary outcomes
Procedural Success
Time frame: Day 0
Technical Success
Time frame: Day 0
Device Performance
Time frame: Day 0
Procedural Time
Time frame: Day 0
Fluoroscopic Time
Time frame: Day 0
CTO Crossing Time
Time frame: Day 0
Use of Assist Devices
Time frame: Day 0
Contrast/Flush Volumes
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Avinger web siteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Selmon, MD principal investigator
Austin Heart Hospital
Arne Schwindt, MD principal investigator
Muenster Hospital
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTO crossing in femoropopliteal arteries CONNECT II in people with Total Atherosclerotic Occlusion of Femoral Artery, run by Avinger, Inc. at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.