An observational study in Coronary Artery Disease, sponsored by Sahajanand Medical Technologies Limited. Recruiting at 7 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Sahajanand Medical Technologies Limited · Observational
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Sahajanand Medical Technologies Limited is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care
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.
Time frame: 12 months
Target Vessel Failure (TVF)
TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR)
Time frame: 12 months
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
Time frame: 12 months
Stent Thrombosis
Stent thrombosis rates according to ARC classification
Time frame: 12 months
All Deaths
Cardiac death and non-cardiac death (vascular and non-cardiovascular)
Time frame: 12 months
Any Myocardial Infarction (MI)
Q wave and non-Q wave MI
Time frame: 12 months
Any Repeat Revascularization
Target lesion revascularization (TLR) and target vessel revascularization (TVR)
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
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Sahajanand Medical Technologies Limited