Trials / Completed
CompletedNCT03229993
OCT in Borderline Coronary Artery Lesions
The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis. It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.
Conditions
- Optical Coherence Tomography (OCT)
- Percutaneous Coronary Intervention (PCI)
- Single-Photon Emission Computed Tomography (SPECT)
- Coronary Angiography (CAG)
- Borderline Coronary Artery Lesions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | OCT | OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions |
Timeline
- Start date
- 2017-12-31
- Primary completion
- 2018-01-31
- Completion
- 2019-12-31
- First posted
- 2017-07-26
- Last updated
- 2020-07-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03229993. Inclusion in this directory is not an endorsement.