Coronary Artery DiseaseNCT03443999
S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System
An observational study of Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 7 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Supraflex Family Sirolimus-eluting Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 7 sitesNetherlands
- Study dates
- 27 Feb 2018to Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥ 18 years
- 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
- Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care.
- The patient is willing and able to cooperate with study procedures and required follow up visits
Who cannot join
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
- Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Recruiting
Tergooi Ziekenhuis
Blaricum, North Holland, 1261 AN
- Recruiting
Amphia Ziekenhuis
Breda, North Brabant, 4818 CK Breda
- Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, Post bus 444 3300 AK
- Recruiting
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
- Recruiting
Medical Center Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
- Recruiting
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ
- Recruiting
ZorgSaam Hospital
Terneuzen, Zeeuws- Vlaanderen, 4535 PA
About this study
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Supraflex Family Sirolimus-eluting Coronary Stent System
- Keywords
- Coronary Artery Disease, Sirolimus-eluting Stent, Biodegradable Polymers
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraflex Family Sirolimus-eluting Coronary Stent SystemDevice
Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Target Vessel Failure (TVF)
TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR)
Measured: 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
Measured: 12 months
Stent Thrombosis
Stent thrombosis rates according to ARC classification
Measured: 12 months
All Deaths
Cardiac death and non-cardiac death (vascular and non-cardiovascular)
Measured: 12 months
Any Myocardial Infarction (MI)
Q wave and non-Q wave MI
Measured: 12 months
Any Repeat Revascularization
Target lesion revascularization (TLR) and target vessel revascularization (TVR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start27 Feb 2018
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sahajanand Medical Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. A.J.J. IJsselmuiden, MD., Principal investigator, Amphia Hospital, Breda, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443999
- Sponsor's protocol ID
- SFLX/Netherlands/001
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2018
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population
- ClinicalTrials.gov ID
- NCT03443999
- Acronym / sponsor ID
- SFLX/Netherlands/001
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Sirolimus-eluting Stent, Biodegradable Polymers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Sahajanand Medical Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- 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
- Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care.
- The patient is willing and able to cooperate with study procedures and required follow up visits
Key exclusion criteria (4 listed)
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
- Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraflex Family Sirolimus-eluting Coronary Stent SystemPatient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care | Device | – |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
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.
6 secondary outcomes
Target Vessel Failure (TVF)
Time frame: 12 months
Major Adverse Cardiac Events (MACE)
Time frame: 12 months
Stent Thrombosis
Time frame: 12 months
All Deaths
Time frame: 12 months
Any Myocardial Infarction (MI)
Time frame: 12 months
Any Repeat Revascularization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. A.J.J. IJsselmuiden, MD. principal investigator
Amphia Hospital, Breda, The Netherlands
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vibhor Bhatia (+919049528863, vibhor.bhatia@sahmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.