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| Name | Class |
|---|---|
| Bristol Royal Infirmary | UNKNOWN |
| Golden Jubilee National Hospital | OTHER_GOV |
| Royal Infirmary of Edinburgh | OTHER |
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Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular Scaffold (BVS).
This is a pilot study, with the aim of hypothesis generation. This research aims to establish the feasibility and safety of treating chronic total occlusions using dissection and re-entry techniques in combination with everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS).
Primary aims of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTO PCI with Absorb BVS | Other | Single arm observational after successful CTO PCI with Absorb BVS after antegrade or retrograde dissection and re-entry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTO PCI using Absorb Bioresorbable Vascular Scaffolds | Device | CTO PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure as per ARC criteria (composite occurrence of any revascularization of the target lesion, myocardial infarction (MI) related to the target vessel, or cardiac death) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison Murphy | Contact | 00442890636349 | alison.murphy@belfasttrust.hscni.net |
| Name | Affiliation | Role |
|---|---|---|
| Simon J Walsh, MD | Belfast Health and Social Care Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast Health & Social Care Trust | Recruiting | Belfast | BT12 6BA | United Kingdom |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 3, 2022 | |
| Reset | Apr 6, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 3, 2022 | Apr 6, 2022 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |