coronary heart disease
Conditions
Interventions
Control group:rountine PCI except DCB
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 60 years; 2. Patients with stable angina, unstable angina or non-ST elevation myocardial infarction; 3. Patients with de novo true BLs (Medina 1,1,10,1,11,0,1) and the diameter of the MV 2.5 mm and the SB 2.25 mm by visually angiographic estimation; 4. Lesions suitable to PCI and to 2-stent implantation as necessary; 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 distal left main CBLs; 2. Lesions unsuitable to PCI (SYNTAX score700x10^9/L, white count 3x10^9/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 |
|---|---|
| Cardiac death;Nonfatal target-vessel associated myocardial infarction;target lesion thrombosis;ischemia-driven target lesion revascularization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe intraoperative vascular dissection (type c above) or/and acute vascular occlusion;salvage main branch and/or side branch stent implantation during intervention;Perioperative or hospitalized emergency target lesion revascularization, acute instent thrombosis;Perioperative or hospitalized acute myocardium infarction,procedure-related myocardial necrotic biomarkers release;The incidence rate of restenosis in the main branch stent, the main branch segment and the side branch 1 year after the;The rate of the major adverse cardiac events (MACE) 1 year after intevention including cardiac death, Q- or non-Q-wave myocardial infarction (QMI or NQMI), instent thrombosis (IST), ischemia-driven target lesion revascularization (iTLR);All-cause death, myocardial infarction, and any vascular reconstruction (including target lesion, target and non-target vascular reconstruction) 1 year after intevention;According to the ARC definition of instent thrombosis (IST), including acute, subacute, late, extremely late IST;Cardiac function graded by the New York Heart Association (HYHA);The Canadian cardiovascular society angina pectoris classification (CCS) or Braunwald angina classification; | — |
Countries
China
Contacts
Public ContactLianglong Chen
Fujian Medical University Union Hospital
Outcome results
None listed