Evaluating the effectiveness and safety of Xience Skypoint stents in treating coronary artery disease
a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease
Asan Medical Center · NCT05981911
This study is testing how well and safely XIENCE Skypoint stents work for people with coronary artery disease compared to other similar stents in everyday medical practice.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05981911 on ClinicalTrials.gov |
What this trial studies
This study aims to assess how effective and safe XIENCE Skypoint stents are when used in routine clinical practice, compared to other drug-eluting stents. It involves observing patients who are receiving these stents and collecting data on their outcomes. The study will focus on real-world applications rather than controlled environments, providing insights into the stents' performance in everyday clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 19 and older who are receiving Xience Skypoint stents.
Not a fit: Patients with terminal illnesses or those experiencing cardiogenic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the effectiveness and safety of Xience Skypoint stents, potentially leading to improved treatment options for patients with coronary artery disease.
How similar studies have performed: Other studies evaluating the effectiveness of drug-eluting stents have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥ 19 years old 2. Patients receiving Xience-Skypoint™ stents. 3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site. Exclusion Criteria: 1. Patients with a mixture of other DESs 2. Terminal illness with life expectancy \<1 year 3. Patients with cardiogenic shock
Where this trial is running
Seoul
- Asan Medical Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Jung-hee Ham, Project manager
- Email: cvcrc5@amc.seoul.kr
- Phone: 82230104728
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.
Conditions: Coronary Artery Disease, drug eluting stent, Percutaneous Coronary Intervention