Evaluating the safety and effectiveness of rotational atherectomy in clinical practice
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study
This study is testing how safe and effective rotational atherectomy is for patients aged 19 and older in real-life hospital settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 8 sites (Bucheon-si and 7 other locations) |
| Trial ID | NCT03427996 on ClinicalTrials.gov |
What this trial studies
This observational study assesses how effective and safe rotational atherectomy is when used in routine clinical settings. It involves patients aged 19 and older who have undergone the procedure and have provided informed consent. The study aims to gather real-world data on patient outcomes following the intervention, contributing to a better understanding of its clinical utility. The research is conducted across multiple hospitals in South Korea.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 19 and older who have received rotational atherectomy.
Not a fit: Patients with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of rotational atherectomy, potentially improving treatment strategies for patients with coronary artery disease.
How similar studies have performed: While this study focuses on routine clinical practice, similar studies evaluating rotational atherectomy have shown promising results, indicating its potential effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 19 years old * Patients who received rotational atherectomy * 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: * Life expectancy \<1y
Where this trial is running
Bucheon-si and 7 other locations
- Soon Chun Hyang University Hospital Bucheon — Bucheon-si, South Korea (Recruiting)
- Daegu Catholic University Medical Center — Daegu, South Korea (Recruiting)
- Chungnam National University Hospital — Daejeon, South Korea (Terminated)
- The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon, South Korea (Withdrawn)
- Chonnam National University Hospital — Gwangju, South Korea (Not_yet_recruiting)
- Inje University Pusan Paik Hospital — Pusan, South Korea (Terminated)
- Bundang CHA Hospital — Seongnam, South Korea (Terminated)
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Seung-jung Park, MD
- Email: sjpark@amc.seoul.kr
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.