Coronary Chronic Total Occlusion
Conditions
Keywords
CTO, Chronic Total Occlusion, Revascularization
Brief summary
A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.
Interventions
DEVICECiTop™ ExPander™ Guidewire
Chronic Total Occlusion guidewire
Sponsors
Ovalum
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained prior to any trial activities. 2. Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see
Exclusion criteria
). 3. Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications | during procedure, 1day, 1week and 30 days post procedure |
Secondary
| Measure | Time frame |
|---|---|
| Successful stenting | During procedure, Day1, Day7 and Day30 post procedure |
| Wire crossing duration | during procedure |
| No mechanical damage to the device during | during procedure |
| Amount of contrast | during procedure |
| Maneuverability of the CiTop™ up to the occlusion | during procedure |
| Fluoroscopy time | during procedure |
Countries
Germany, South Africa
Outcome results
None listed