Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
CONNECTII
A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
1 other identifier
interventional
100
3 countries
17
Brief Summary
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
March 18, 2015
CompletedMarch 22, 2021
March 1, 2021
4 months
February 15, 2012
March 5, 2015
March 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (8)
Procedural Success
Day 0
Technical Success
Day 0
Device Performance
Day 0
Procedural Time
Day 0
Fluoroscopic Time
Day 0
- +3 more secondary outcomes
Study Arms (1)
Ocelot System
EXPERIMENTALCTO crossing in femoropopliteal arteries using the Ocelot System
Interventions
CTO crossing in femoropopliteal arteries using the Ocelot System
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avinger, Inc.lead
Study Sites (17)
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Sutter Memorial
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
Related Links
Results Point of Contact
- Title
- Matthew Selmon, MD
- Organization
- Austin Heart
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Selmon, MD
Austin Heart Hospital
- PRINCIPAL INVESTIGATOR
Arne Schwindt, MD
Muenster Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
February 23, 2012
Study Start
February 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 22, 2021
Results First Posted
March 18, 2015
Record last verified: 2021-03