Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II (CONNECTII)
|ClinicalTrials.gov Identifier: NCT01537302|
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Total Atherosclerotic Occlusion of Femoral Artery||Device: CTO crossing in femoropopliteal arteries CONNECT II||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries|
|Study Start Date :||February 2012|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
|Experimental: Treatment arm||
Device: CTO crossing in femoropopliteal arteries CONNECT II
CTO crossing in femoropopliteal arteries using the Ocelot System
- 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.
- Procedural Success [ Time Frame: 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.
- Technical Success [ Time Frame: Day 0 ]Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.
- Device Performance [ Time Frame: 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 Times [ Time Frame: Day 0 ]Evaluation of procedural times.
- Fluoroscopic Times [ Time Frame: Day 0 ]Evaluation of fluoroscopic times.
- Crossing Times [ Time Frame: Day 0 ]Evaluation of crossing times.
- Use of Assist Devices [ Time Frame: Day 0 ]Evaluation of the use of assist devices.
- Contrast/Flush Volumes [ Time Frame: Day 0 ]Evaluation of the contrast/flush volumes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537302
|United States, Arkansas|
|Arkansas Heart Hospital|
|Little Rock, Arkansas, United States, 72211|
|United States, California|
|Sacramento, California, United States, 95619|
|United States, Illinois|
|Cardiovascular Associates - Alexian Brothers Medical Center|
|Elk Grove Village, Illinois, United States, 60007|
|United States, Indiana|
|St. Joseph's Hospital|
|Fort Wayne, Indiana, United States, 46802|
|United States, Michigan|
|St. John Hospital and Medical Center|
|Detoit, Michigan, United States, 48236|
|Detroit Medical Center|
|Detroit, Michigan, United States, 48201|
|United States, Mississippi|
|St. Dominic Hospital|
|Jackson, Mississippi, United States, 39216|
|United States, New Jersey|
|Deborah Heart and Lung Center|
|Browns Mills, New Jersey, United States, 08015|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|Jobst Vascular Center|
|Toledo, Ohio, United States, 43606|
|United States, Pennsylvania|
|Bryn Mawr Hospital|
|Bryn Mawr, Pennsylvania, United States, 19010|
|United States, Texas|
|Austin, Texas, United States, 78756|
|El Paso Cardiology Associates|
|El Paso,, Texas, United States, 79902|
|The Heart Hospital Baylor Plano|
|Plano, Texas, United States, 75093|
|Leipzig, Germany, 04289|
|Muenster, Germany, 48145|
|Mirano, Italy, 30035|
|Principal Investigator:||Matthew Selmon, MD||Austin Heart Hospital|
|Principal Investigator:||Arne Schwindt, MD||Muenster Hospital|