Evaluating FFR Guided PCI in Coronary Tandem Lesions
A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
This study is testing if using a special measurement called FFR to guide heart artery procedures helps people with multiple blockages feel better and have better results than the usual methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 14 sites (Seoul, Songpa-gu and 13 other locations) |
| Trial ID | NCT02797561 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of using fractional flow reserve (FFR) to guide percutaneous coronary intervention (PCI) in patients with tandem lesions in their coronary arteries. It involves a five-year follow-up to monitor outcomes and effectiveness. The study will include patients who have undergone FFR evaluation of their tandem lesions and have provided written consent. The goal is to determine if FFR guidance improves patient outcomes compared to standard practices.
Who should consider this trial
Good fit: Ideal candidates are patients with tandem coronary lesions who have been evaluated using FFR.
Not a fit: Patients with severe coronary conditions, such as TIMI flow less than 3 or severe calcification, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with complex coronary artery disease.
How similar studies have performed: Other studies have shown promising results with FFR-guided interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Tandem lesion evaluated by FFR * Written consent Exclusion Criteria: * TIMI flow \< 3 * Grafted vessel * Left ventricular ejection fraction \< 30% * Severe calcification and/or severe tortuosity * Uncontrolled coronary spasm * Life expectancy \< 2 years * Planned high risk surgery * Pregnancy or breast-feeding
Where this trial is running
Seoul, Songpa-gu and 13 other locations
- Asan Medical Center — Seoul, Songpa-gu, Korea, Republic of (Recruiting)
- Soon Chun Hyang University Hospital Bucheon — Bucheon, Korea, Republic of (Recruiting)
- Gangwon National Univ. Hospital — Chuncheon, Korea, Republic of (Recruiting)
- Daegu Catholic University Medical Center — Daegu, Korea, Republic of (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, Korea, Republic of (Recruiting)
- Chungnam National University Hospital — Daejeon, Korea, Republic of (Recruiting)
- Gangneung Asan Hospital — Gangneung, Korea, Republic of (Withdrawn)
- Inje University Ilsan Paik Hospital — Ilsan, Korea, Republic of (Recruiting)
- Bundang CHA Hospital — Seongnam, Korea, Republic of (Recruiting)
- Seoul National University Bundang hospital — Seongnam, Korea, Republic of (Recruiting)
- Kangbuk Samsung Hospital — Seoul, Korea, Republic of (Withdrawn)
- Seoul National University hospital — Seoul, Korea, Republic of (Recruiting)
- Wonju Severance Christian Hospital — Wonju, Korea, Republic of (Recruiting)
- Pusan National University Yangsan Hospital — Yangsan, Korea, Republic of (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.