coronary heart disease
Conditions
Interventions
Test group:DCB
Control group:PTCA balloon
Single arm group:DCB
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 75 years; 2. Patients with stable angina, unstable angina or non-ST elevation myocardial infarction; 3. Patients with de novo lesions and the diameter of vessels less than 2.5 mm by visually angiographic estimation, diameter of collateral vessels < 2.25 mm; 4. Lesions suitable to PCI ; 5. Patients willing to participating and following up; 6. Patients/guardian understanding the protocol requirement with written consent.
Exclusion criteria
Exclusion criteria: 1. Patients with STEMI less than 1 week; 2. CABG patients; 3. Lesions unsuitable to PCI such as ISR, bifurcation lesion and thromosis; 4. Patients Intolerance to dual-antiplatelet therapy; 5. Patients with obvious hemopoietic system abnormalities, for instances, plt 700 x 10^9/L, white count 3 x 10^9/L; 6. Patients with bleeding or bleeding tendency, for instances, active gastrointestinal ulcer, recent ischemic or prior hemorrhagic stroke, cerebral occupied lesions, recent cerebral injuries, any internal bleeding with uneasy hemostasis etc.; 7. Patients with other organ dysfunction, for instances, hepatic (ALT > 5 URL) or renal (eGRF > 30ml/min/1.73m2) dysfunction, congestive heart failure (NYHA > 3); 8. Patients complicating severe illness with life expectation of >12 months; 9. Women with or planning to pregnancy; 10. Patients with contraindications or allergies to the stent platforms or the associated medications, for instances, stent eluting drugs, stainless steel or alloy, aspirin, P2Y12 inhibitors, contrast agents, etc.; 11. Patients participating in another drug or instrument ongoing trial, or planning to participate in another drug or instrument trial within 12 month post-procedurally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss;Major adverse cardiac events, MACE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sestenosis;Success rate of operation;Success rate of device;Target lesion revascularizition, TLR; | — |
Countries
China
Contacts
Public ContactSong Xiantao
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed