Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT06373120
Eligibility Criteria:
Inclusion Criteria:
1. 18 Years to 90 Years
2. The Heart Team determined that the patients required coronary artery revascularization, but there is a high risk of CABG or the patients refuses CABG. After evaluation by the Heart Team, it was concluded that the patients can benefit from revascularization by undergoing high risk PCI
3. The subject is diagnosed with acute or chronic coronary syndrome, and
1. LVEF≤ 35% or
2. LVEF ≤ 40% and NYHA Classification is III or IV
4. Patients who are able to give informed consent and complete the follow-up
Image inclusion criteria
1. At least two vessel chronic total occlusions (CTOs) (diameter of occluded artery ≥ 2.5mm)
2. Unprotected left main coronary artery disease, and meeting one or more complex PCI maneuver criteria
3. Three-vessel disease and meeting two or more complex PCI criteria
Complex PCI maneuvers are defined as:
1. Bifurcation require the treatment of both branches (including stents or PTCA)
2. Calcification require Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy
3. Severe tortuosity
4. Target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 points)
Exclusion Criteria
1. Had mechanical circulatory support treatment (such as IABP, ECMO, pVAD) before randomization
2. Acute myocardial infarction or with thrombolytic treatment within 7 days
3. Cardiopulmonary resuscitation within 24 hours
4. Cardiogenic shock (systolic blood pressure \< 90 mmHg for more than 30 minutes or requiring vasoactive drugs to maintain systolic blood pressure above 90 mmHg) or hemodynamically unstable
5. pVAD and ECMO cannot be inserted or contraindicated (including but not limited to left ventricular mural thrombus, artificial aortic valve or cardiac contraction device, moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency, peripheral stents, tortuosity, dissection and other severe vascular diseases obstructing the insertion of the study device, aortic dissection, aneurysm or severe abnormalities of the ascending aorta and/or aortic arch, red blood cell fragility or blood disorders, hypertrophic obstructive cardiomyopathy)
6. Abnormal coagulation function (routine blood test indicates platelet count less than 50×109/L, or more than 700×109/L)
7. Active visceral bleeding occurred within 1 month
8. Ischemic or hemorrhagic stroke occurred within 1 month
9. Known contraindication to antiplatelet and anticoagulant medications
10. Known contraindication to medications such as Heparin or contrast.
11. Need for dialysis treatment
12. Active infection
13. Expected life span of less than one year
14. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
15. Currently participating in another trial and not yet at its primary endpoint
16. Severe pulmonary arterial hypertension
17. Severe right heart failure or severe tricuspid regurgitation
18. Unforeseen circumstances that the researcher has deemed to be inappropriate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06373120
Study Brief:
Protocol Section:
NCT06373120