CHD - Coronary Heart Disease, In-stent Restenosis, Percutaneous Coronary Intervention
Conditions
Brief summary
This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
Interventions
PROCEDUREPercutaneous Coronary Intervention under OCT
After randomization, subjects receive primary PCI under the guiding of OCT
PROCEDUREPercutaneous Coronary Intervention under Angiography
After randomization, subjects receive primary PCI under the guiding of angiography
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Patients with angina or evidence of myocardial ischaemia * Patients with restenotic lesions in a previously DES area of a coronary artery * Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation) * The stent diameter of DES-ISR is 2.5mm to 4.0mm * Target lesion length \< 30mm * Target lesion stenosis ≥ 70% diameter stenosis on visual assessment, or ≥ 50% diameter stenosis and with evidence of myocardial ischaemia ischemic
Exclusion criteria
* Patients with acute myocardial infarction with 1 week * Patients with evidence of extensive thrombosis in the target vessel * Patients with left main coronary artery disease * Patients with cardiogenic shock, left ventricular ejection fraction \< 40%,significant renal dysfunction and severe heart valve disease * Patients who had cerebral stroke within 6 months before PCI * Patients with a life expectancy \< 1 year * Patients not able to adhere to follow-up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late loss at 9 months follow-up | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Rate of 9-month binary restenosis | 9 months |
| Number of Participants with target lesion failure (TLF) | 12 months |
| Rates of acute success | 1 month |
| Number of participants with all-cause death | 12 months |
| Rate of myocardial infarction | 12 months |
| Rate of major adverse cardiovascular events | 12 months |
Countries
China
Contacts
Primary ContactYundai Chen
Backup ContactLei Gao
Outcome results
None listed