NCT03443999 S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System
| NCT ID | NCT03443999 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahajanand Medical Technologies Limited |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2018-02-27 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2018-02-27 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Dr. A.J.J. IJsselmuiden, MD.
PRINCIPAL INVESTIGATOR
Amphia Hospital, Breda, The Netherlands
Frequently Asked Questions
Who can join the NCT03443999 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03443999 currently recruiting?
Yes, NCT03443999 is actively recruiting participants. Contact the research team at vibhor.bhatia@sahmed.com for enrollment information.
Where is the NCT03443999 trial being conducted?
This trial is being conducted at Breda, Netherlands, Eindhoven, Netherlands, Blaricum, Netherlands, Leeuwarden, Netherlands and 3 additional locations.
Who is sponsoring the NCT03443999 clinical trial?
NCT03443999 is sponsored by Sahajanand Medical Technologies Limited. The principal investigator is Dr. A.J.J. IJsselmuiden, MD. at Amphia Hospital, Breda, The Netherlands. The trial plans to enroll 10,000 participants.