N/A
N=100
Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
Total Atherosclerotic Occlusion of Femoral Artery
Bottom Line
View on ClinicalTrials.gov: NCT01537302 ↗Enrolled (actual)
100
Serious AEs
26.0%
Results posted
Mar 2015
Primary outcome: Primary: Primary Safety Endpoint — 2 Percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CTO crossing in femoropopliteal arteries CONNECT II (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Avinger, Inc.
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint |
2 | — |
| PRIMARY Primary Efficacy Endpoint |
97 | — |
| SECONDARY Procedural Success |
95 | — |
| SECONDARY Technical Success |
72 | — |
| SECONDARY Device Performance |
87; 13; 0; 0; 0; 76 | — |
| SECONDARY Procedural Time |
107.3 | — |
| SECONDARY Fluoroscopic Time |
38.6 | — |
| SECONDARY CTO Crossing Time |
32.9 | — |
| SECONDARY Use of Assist Devices |
16.8; 79.1 | — |
| SECONDARY Contrast/Flush Volumes |
33.1; 223.0; 124.5 | — |
Summary
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01537302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.