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Biosensors, the Sponsor would like to determine if the Biosensors Microcatheter is safe and effective in treating patients with CTO by assessing a composite of in-hospital cardiac death or myocardial infarction and device success (defined as successfully facilitate placement of a guidewire beyond the occluded coronary segment), respectively.
Prospective, multi-center, open-label single-arm trial designed to enroll 100 patients undergoing attempted CTO-PCI at up to 10 centers in the United Kingdom and N. Ireland. For assessment of efficacy, the ability of the BM to successfully facilitate placement of a guidewire beyond the occluded coronary segment will be assessed. Patients will be followed up until hospital discharge or 7 days post index procedure, whichever comes first. For the assessment of safety, the incidence of in-hospital cardiac death or myocardial infarction will be assessed at hospital discharge or 7 days post index procedure, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biosensors Microcatheter (BM) | Experimental | Use of Biosensors Microcatheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcatheter | Device | Only to be used if Biosensor Microcatheter does not perform accordingly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percentage of patients with device success | Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. |
| Safety: Percentage of patients with composite of in-hospital cardiac death or myocardial infarction. | Composite of in-hospital cardiac death or myocardial infarction. | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with technical success | Technical success is defined as achievement of TIMI grade 2 antegrade flow with less than 50% residual stenosis of the target CTO lesion at procedure end | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. |
| Percentage of patients with procedural success |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with device-related perforation | Device-related perforation at the site of target coronary lesion and/or its proximal reference segment including donor artery or collateral | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. |
| Percentage of patients with device failure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Sprattt, Professor | St. George's Hospital, London | Principal Investigator |
| Margaret MCENTEGART, Dr. | Golden Jubilee National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basildon and Thurrock University | Basildon | Essex | SS16 5NL | United Kingdom | ||
| Golden Jubilee Hospital, |
The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.
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Procedural success defined as technical success plus the absence of in-hospital MACE (death, myocardial infarction or clinically-driven target vessel revascularization (cd TVR) |
| Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. |
| Percentage of patients with crossing success | Crossing success defined as the BM crossing the lesion | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. |
Device failure is defined as:
|
| Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. |
| Clydebank |
| Glasgow, Scotland |
| G81 4DY |
| United Kingdom |
| St George's Hospital, Blackshaw Road, | London | Tooting | SW17 OQT | United Kingdom |
| Royal Victoria Hospital | Belfast | BT126BA | United Kingdom |
| Bristol Heart Institute, UHBW NHS Trust | Bristol | BS2 8HW | United Kingdom |
| London North West University Healthcare Nhs Trust | Harrow | HA1 3UJ | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| Glenfield Hospital | Leicester | LE5 4PW | United Kingdom |
| University Hospital of Wales | Wales | United Kingdom |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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