Young and middle-aged acute myocardial infarction
Conditions
Interventions
Experimental group:Balloon expansion
Sponsors
Inner Mongolia Autonomous Region People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Males aged 18-50 or non-pregnant women; (2) chest elevation occurred within 12 hours of ST elevation in acute myocardial infarction; (3) single or two in situ coronary vascular lesions; (4) complete occlusion or thrombus burden lesions; (5) Patients were able to understand the purpose of the trial, voluntarily signed the informed consent form, and agreed to receive clinical follow-up of 1 month, 6 months and 1 year, and 9-month angiographic follow-up; (6) Target lesions can be successfully pre-expanded (guide wire can pass through lesions, residual stenosis = 30% in the lumen of the blood vessel, infinite flow dissection or thrombus after pretreatment).
Exclusion criteria
Exclusion criteria: (1) Researchers believe that it is not suitable for patients participating in the trial; (2) pregnant and lactating women; (3) Patients with severe congestive heart failure or NYHA class IV heart failure; (4) Patients with bleeding constitution who cannot use anticoagulant or antiplatelet drugs for a long time; (5) stroke patients occurred in the past 6 months; (6) Patients with severe renal failure (GFR = 30 ml/min); (7) heart transplant patients; (8) Patients cannot tolerate aspirin and/or P2Y12 receptor inhibitors; (9) Patients with allergies to paclitaxel, PLGA, or contrast agents; (10) The patient had a history of peptic ulcer or gastrointestinal bleeding in the past 6 months; (11) The patient has participated in other drug or device clinical trials and has not yet completed the expected primary endpoint follow-up of the clinical trial enrolled. Imaging related: (12) Three coronary vascular lesions or more; (13) left main trunk and 2 mm open lesions; (14) There are severely distorted or severely calcified lesions proximal to the target lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 9 months after target lesion treatment, late lumen loss in target lesion segment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate (%);Success rate of surgery (%);9 months after the target lesion segmental restenosis rate (%);Clinically-driven target lesion revascularization;Clinically-driven target vessel revascularization;Major device adverse cardiac events;ARC-defined incidence of thrombotic events;Subject-related cardiovascular adverse events; | — |
Countries
China
Contacts
Public ContactZhiyong Wang
Inner Mongolia Autonomous Region People's Hospital
Outcome results
None listed