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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.
To overcome the potential drawback of the durable polymer a new generation of drug-eluting stent (DES) with a biodegradable polymer has been designed. The first-generation sirolimus-eluting or paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. More recently, second generation DES have been developed not only to improve long-term DES safety but also to facilitate the procedure by using a cobalt-chromium (Co-Cr) stent platform. Co-Cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform.
The Sahajanand Medical Technologies Pvt. Ltd. (SMT) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a Co-Cr stent platform. The purpose of this registry is to evaluate the Supraflex Family sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraflex Family Sirolimus-eluting Coronary Stent System | Device | Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Major Adverse Cardiac Events (MACE) |
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Inclusion Criteria:
Exclusion Criteria:
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Real-world patient population assigned for PCI who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Supraflex Family sirolimus-eluting stent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vibhor Bhatia | Contact | +919049528863 | vibhor.bhatia@sahmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. A.J.J. IJsselmuiden, MD. | Amphia Hospital, Breda, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphia Ziekenhuis | Recruiting | Breda | North Brabant | 4818 CK Breda | Netherlands | |
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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 |
| Stent Thrombosis | Stent thrombosis rates according to ARC classification | 12 months |
| All Deaths | Cardiac death and non-cardiac death (vascular and non-cardiovascular) | 12 months |
| Any Myocardial Infarction (MI) | Q wave and non-Q wave MI | 12 months |
| Any Repeat Revascularization | Target lesion revascularization (TLR) and target vessel revascularization (TVR) | 12 months |
| Catharina Ziekenhuis |
| Recruiting |
| Eindhoven |
| North Brabant |
| 5623 EJ |
| Netherlands |
| Tergooi Ziekenhuis | Recruiting | Blaricum | North Holland | 1261 AN | Netherlands |
| Medical Center Leeuwarden | Recruiting | Leeuwarden | Provincie Friesland | 8934 AD | Netherlands |
| Albert Schweitzer Ziekenhuis | Recruiting | Dordrecht | South Holland | Post bus 444 3300 AK | Netherlands |
| Maasstad Ziekenhuis | Recruiting | Rotterdam | South Holland | 3079 DZ | Netherlands |
| ZorgSaam Hospital | Recruiting | Terneuzen | Zeeuws- Vlaanderen | 4535 PA | Netherlands |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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