Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System
Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population
This study is testing a new type of heart stent to see if it is safe and effective for people with coronary artery disease who need stents.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sahajanand Medical Technologies Limited Industry-sponsored |
| Locations | 7 sites (Breda, North Brabant and 6 other locations) |
| Trial ID | NCT03443999 on ClinicalTrials.gov |
What this trial studies
This registry aims to assess the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in patients requiring stent implantation for coronary artery disease. It focuses on a new generation of drug-eluting stents that utilize a biodegradable polymer and a cobalt-chromium platform, which enhances flexibility and deliverability while maintaining strength. The study will collect data from a real-world patient population to evaluate the stent's performance in routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require elective implantation of the Supraflex Family stent.
Not a fit: Patients who are pregnant, lactating, or have a high probability of non-adherence to follow-up requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term safety and effectiveness of a new stent technology for patients with coronary artery disease.
How similar studies have performed: Other studies have shown promise with biodegradable polymer stents, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Breda, North Brabant and 6 other locations
- Amphia Ziekenhuis — Breda, North Brabant, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, North Brabant, Netherlands (Recruiting)
- Tergooi Ziekenhuis — Blaricum, North Holland, Netherlands (Recruiting)
- Medical Center Leeuwarden — Leeuwarden, Provincie Friesland, Netherlands (Recruiting)
- Albert Schweitzer Ziekenhuis — Dordrecht, South Holland, Netherlands (Recruiting)
- Maasstad Ziekenhuis — Rotterdam, South Holland, Netherlands (Recruiting)
- ZorgSaam Hospital — Terneuzen, Zeeuws- Vlaanderen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Dr. A.J.J. IJsselmuiden, MD. — Amphia Hospital, Breda, The Netherlands
- Study coordinator: Vibhor Bhatia
- Email: vibhor.bhatia@sahmed.com
- Phone: +919049528863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.