Trials / Recruiting
RecruitingNCT06182683
Concurrent OCT and FFR-guided PCI in CAD
Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- Sponsor
- Korea University Guro Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease.
Detailed description
Most previous clinical trials have assessed various interventional strategies guided by intravascular imaging (intravascular imaging-guided PCI), fractional flow reserve (FFR-guided PCI), or conventional angiography (angiography-guided PCI) to compare differences in treatment outcomes. Until now, it remains unclear whether optimizing procedures based on both intravascular imaging and fractional flow reserve indices would lead to improved treatment outcomes compared to PCI guided solely by conventional angiography. Moreover, there are no studies comparing a treatment strategy that combines optical coherence tomography (OCT) and FFR to angiography-guided procedures. Hence, this study aims to compare the clinical effectiveness and therapeutic impact of concurrent guidance using FFR and OCT in patients undergoing coronary artery stent implantation, as compared to procedures guided solely by conventional angiography.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | optical coherence tomography and fractional flow reserve | The assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices. |
| DIAGNOSTIC_TEST | Coronary angiography | The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography |
Timeline
- Start date
- 2023-11-30
- Primary completion
- 2028-12-31
- Completion
- 2029-12-31
- First posted
- 2023-12-27
- Last updated
- 2023-12-27
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06182683. Inclusion in this directory is not an endorsement.