Coronary artery disease
Conditions
Interventions
Stage 1:Novlead console plus Maquet balloon
Stage 2:Novlead console plus Novlead balloon
Sponsors
Xijing Hospital, the First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Patients with critical cardiovascular disease who exhibit hemodynamic instability and necessitate circulatory support: systolic blood pressure < 90 mmHg for more than 30 minutes, or requiring catecholamines to sustain a systolic blood pressure above 90 mmHg; 2.The IABP catheter can be successfully inserted through arterial access. 3.Patients who understand the study's objectives, voluntarily participate, sign the informed consent form, and are willing to undergo regular follow-up.
Exclusion criteria
Exclusion criteria: Any subject meeting any of the below clinical exclusion criteria will not be eligible for enrolment 1. Age 90 years. 2. Patient is a woman who is pregnant or nursing. 3. Patients who have contraindications of IABP use: (1)Moderate-to-severe aortic valve insufficiency (2)Rupture of sinus of valsalva aneurysm (3)Aortic disease: aortic dissection, aortic aneurysm, aortic trauma, and severe aortic atherosclerosis (4)Severe peripheral arterial disease, such as severe stenosis and calcification of the iliac artery (5)Cardiac arrest or ventricular fibrillation (6)Severe bleeding tendency and hemorrhagic diseases, such as active bleeding or severe thrombocytopenia (7)Severe anemia (8)Irreversible brain damage or acute cerebral hemorrhage 4. Patients who are unable to receive antiplatelet or anticoagulation therapy, or patients who are allergic to heparin. 5. Currently participating in another trial and not yet at its primary endpoint. 6. Any potential medical or mental conditions that the researchers consider inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All adverse events defined by CTCAE;All severe adverse events defined by CTCAE;Adverse events related to IABP;Myocardial markers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedural evaluation;Cunterpulsation pressure;Hemodynamic parameters; | — |
Countries
China
Contacts
Public ContactLing Tao
Xijing Hospital, the First Affiliated Hospital of Air Force Medical University
Outcome results
None listed