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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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The objective of this post marketing observational registry is to evaluate clinical outcomes (safety and performance) in an all-comers population with coronary artery disease (CAD) treated with the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR and planned for an abbreviated (≤ 3 months) dual antiplatelet therapy (DAPT) regimen.
This study is a prospective, observational, multi-country, multi-Centre, single-arm registry designed to evaluate the clinical safety and performance of VIVO ISAR, Polymer Free Sirolimus Eluting Coronary Stent System. The study population is made up of subjects who have undergone PCI using VIVO ISAR and are receiving standard of care short DAPT treatment (≤ 3 months) . Subjects will be screened by site teams and offered the opportunity to participate in the registry after their procedure. Rationale for this study is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent in real world CAD patients with follow-up at 1 month, 3 months and 12 months.
All medications and procedures to be used/ performed in this registry are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
The study does not influence the choice of device utilized nor does it alter the routine standard of care. After a patient has been treated with the Vivo ISAR, informed consent will be requested and the eligible patient will be registered in the study.
Baseline data will be completed using medical notes. All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days, 3 months and 12 months from the baseline PCI procedure date.
The 30 day, 3 months and 12 month telephonic follow up will consist of a verbally report of the DAPT anticoagulation medications continued, about any lab assessments that might have happened, recording of any adverse events, and any interventional treatment that has occurred since previous contact.
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| Measure | Description | Time Frame |
|---|---|---|
| Ischemic endpoint | Cardiovascular death, myocardial infarction (not clearly attributable to a non-target vessel), definite or probable stent thrombosis or urgent target lesion revascularization (TLR). | 12 months |
| Bleeding endpoint | bleeding defined as Bleeding Academic Research Consortium (BARC) class 3 or higher | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Mortality | 12 months |
| Cardiovascular death |
|
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Inclusion Criteria:
Exclusion Criteria:
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A real-world population undergoing percutaneous coronary intervention with VIVO-ISAR (Polymer Free Sirolimus Eluting Coronary Stent) and intended for treatment with ≤ 3 months of DAPT
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diptendu Chatterjee | Contact | 9339948873 | diptenduchatterjee@translumina.in | |
| Deepanshi Thakur | Contact | 9971954733 | deepanshithakur@translumina.in |
| Name | Affiliation | Role |
|---|---|---|
| Prof Adnan Kastrati | German Heart Centre Munich, Germany | Study Chair |
| Prof Azfar Zaman | Freeman Hospital, Newcastle, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zydus Hospitals | Recruiting | Ahmedabad | 380054 | India | ||
| Fortis Hospital |
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| 12 months |
| Myocardial infarction (MI) | Myocardial Infarction (including periprocedural myocardial infarction) as defined per the Fourth Universal Definition of Myocardial Infarction: "Detection of a rise and/or fall of cardiac troponin (cTn) with at least one value above the 99th percentile and with at least one of the following:
| 12 months |
| Stroke | caused either by a clot obstructing the flow of blood to the brain (called an ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (called a hemorrhagic stroke) | 12 months |
| Stent thrombosis (definite/probable) | Definite Stent Thrombosis: Angiographic confirmation of stent thrombosis:
| 12 months |
| Target Lesion Revascularisation (TLR) - Ischemia driven (ID) | A TLR is considered ischemia-driven if angiography at follow-up shows a percent diameter stenosis ≥50% and if one of the following occurs:
| 12 months |
| Urgent TLR | Acute condition post index procedure where urgent revascularization of the target lesion is necessary | 12 months |
| Target vessel revascularisation (TVR) | repeat percutaneous intervention or surgical bypass of any segment of a target vessel. | 12 months |
| BARC class 2 bleeding | any overt, actionable sign of hemorrhage | 12 months |
| Recruiting |
| Bangalore |
| 560076 |
| India |
| Adesh Hospital | Recruiting | Bathinda | 151001 | India |
| PGIMER | Recruiting | Chandigarh | 160012 | India |
| National Heart Institute | Recruiting | Delhi | 11 00 65 | India |
| Fortis Escorts Heart Institute & Research Centre | Recruiting | Delhi | 110025 | India |
|
| Fortis Escorts Heart Institute & Research Centre | Recruiting | Delhi | 110025 | India |
| Medanta-The Medicity | Recruiting | Gurugram | 122001 | India |
| Yashoda Hospitals | Recruiting | Hyderabad | 500081 | India |
| Shalby Hospital | Recruiting | Jabalpur | 482002 | India |
| Fortis Hospital | Recruiting | Kalyān | 421301 | India |
| L.P.S Institute of Cardiology | Recruiting | Kanpur | 208019 | India |
|
| Fortis Hospital | Recruiting | Kolkata | 700107 | India |
| Dr. Ram Manohar Lohia Hospital (RML) | Recruiting | Lucknow | 226010 | India |
| Seva Sadan Hospital | Recruiting | Miraj | 416410 | India |
|
| Fortis | Recruiting | Mohali | 160062 | India |
| Yashodha Hospital | Recruiting | Somājigūda | 500082 | India |
|
| ASREM - Regional Hospitals | Recruiting | Campobasso | 86100 | Italy |
| Montevergine | Recruiting | Mercogliano AV | 83013 | Italy |
| Clinica Mediterranea | Recruiting | Naples | 80122 | Italy |
| University of Padua, Padova | Recruiting | Padova | 35122 | Italy |
| Clinica Pierangeli | Recruiting | Pescara | 65124 | Italy |
| Santo Spirito Hospital | Recruiting | Pescara | 65124 | Italy |
| Tor Vergata University | Recruiting | Roma | 00133 | Italy |
| Amsterdam UMC (University Medical Centers) | Recruiting | Amsterdam | 91105 | Netherlands |
| Tergooi MC | Recruiting | Hilversum | 1213 XZ | Netherlands |
| Viecuri MC | Recruiting | Venlo | 5912 | Netherlands |
| Bedford Hospital | Recruiting | Bedford | MK42 9DJ | United Kingdom |
| Freeman Hospital | Recruiting | Newcastle | NE7 7DN | United Kingdom |
| Derriford Hospitalm Plymouth NHS Trust | Recruiting | Plymouth | PL6 8DH | United Kingdom |
| Salisbury NHS Foundation Trust | Recruiting | Salisbury | SP2 8BJ | United Kingdom |
| Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust | Recruiting | Wigan | WN1 2NN | United Kingdom |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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