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no interest to develop the product
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A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CiTop™ ExPander™ Guidewire | Device | Chronic Total Occlusion guidewire |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Successful stenting | During procedure, Day1, Day7 and Day30 post procedure | |
| Wire crossing duration | during procedure | |
| Fluoroscopy time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HELIOS Klinikum Wuppertal | Wuppertal | D-42117 | Germany | |||
| Sunward Park Hospital |
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| during procedure |
| Amount of contrast | during procedure |
| Maneuverability of the CiTop™ up to the occlusion | during procedure |
| No mechanical damage to the device during | during procedure |
| Boksburg |
| South Africa |
| Sunninghill Hospital | Sunninghill | 2157 | South Africa |