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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.
Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for data collection. This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post-Market Surveillance.
This registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofreedom Ultra | Device | The BioFreedomTM Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically driven Target Lesion Revascularization (TLR) | 12 months | |
| Cardiovascular death (CD) | 12 months | |
| Target Vessel MI |
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Inclusion Criteria:
Exclusion Criteria:
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This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Calvin Bahr, MS | Contact | +41 21 804 80 24 | c.bahr@biosensors.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Barmherzige Brüder | Recruiting | Eisenstadt | Austria |
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| 12 months |
| Target Vessel Revascularization (TVR) | 12 months |
| Stent thrombosis | 12 months |
| Clinique Des Domes Psr | Recruiting | Clermont-Ferrand | France |
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| Klinikum Lippe | Recruiting | Detmold | Germany |
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| Hospital Marques Valdecilla | Recruiting | Santander | Spain |
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| University and Hospital Fribourg | Recruiting | Fribourg | Switzerland |
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| Universitäres Herzzentrum | Recruiting | Zurich | Switzerland |
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| Military hospital | Recruiting | Tunis | Tunisia |
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| Al Qassimi Hospital | Recruiting | Sharjah city | United Arab Emirates |
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| Royal Bournemouth hospital | Recruiting | Bournemouth | United Kingdom |
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| Golden Jubilee National Hospital | Recruiting | Glasgow | United Kingdom |
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