Percutaneous Coronary Intervention (PCI) Clinical Trial
Official title:
The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions
Verified date | July 2020 |
Source | The First Affiliated Hospital with Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | December 31, 2019 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT. Exclusion Criteria: - Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MACEs | The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis. | 12 months | |
Primary | TLR | The incidence of target lesion revascularization (TLR) | 12 months | |
Secondary | Rehospitalization | The incidence of rehospitalization due to cardiac events | 12 months | |
Secondary | Recurrent angina | The incidence of recurrent angina | 12 months |
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