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The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary arteries.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CiTop(tm) Guidewire | Device | CiTop(tm)6 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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| Name | Affiliation | Role |
|---|---|---|
| Keyur Parikh, MD | Chairman,CardioVascular Services,SAL Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.A.L Hospital | Ahmedabad | Gujarat | 380054 | India |
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| ID | Term |
|---|---|
| D054059 | Coronary Occlusion |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| D014652 |
| Vascular Diseases |