Coronary Artery Disease Clinical Trial
Official title:
Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population
The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.
Status | Recruiting |
Enrollment | 7000 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years 2. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form 3. Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care. 4. The patient is willing and able to cooperate with study procedures and required follow up visits Exclusion Criteria: 1. Women with known pregnancy or who are lactating 2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) 3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements 4. Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period |
Country | Name | City | State |
---|---|---|---|
Netherlands | Tergooi Ziekenhuis | Blaricum | North Holland |
Netherlands | Amphia Ziekenhuis | Breda | North Brabant |
Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | South Holland |
Netherlands | Catharina Ziekenhuis | Eindhoven | North Brabant |
Netherlands | Medical Center Leeuwarden | Leeuwarden | Friesland |
Netherlands | Maasstad Ziekenhuis | Rotterdam | South Holland |
Netherlands | ZorgSaam Hospital | Terneuzen | Zeeuws- Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
Sahajanand Medical Technologies Limited |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target Lesion Failure (TLF) | TLF defined as a composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. | 12 months | |
Secondary | Target Vessel Failure (TVF) | TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) | 12 months | |
Secondary | Major Adverse Cardiac Events (MACE) | MACE defined as a composite endpoint of cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods | 12 months | |
Secondary | Stent Thrombosis | Stent thrombosis rates according to ARC classification | 12 months | |
Secondary | All Deaths | Cardiac death and non-cardiac death (vascular and non-cardiovascular) | 12 months | |
Secondary | Any Myocardial Infarction (MI) | Q wave and non-Q wave MI | 12 months | |
Secondary | Any Repeat Revascularization | Target lesion revascularization (TLR) and target vessel revascularization (TVR) | 12 months |
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