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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT04692402
Eligibility Criteria:
Inclusion Criteria:
Subjects meeting all of the inclusion criteria listed below will be included in this study:
1. Index event of ST segment elevation or non-ST segment elevation MI or Unstable Angina defined as:
1. Presentation to hospital with symptoms of myocardial ischemia (Chest pain or angina equivalent) lasting for ≥10 minutes at rest
AND 1 of the following:
2. Persistent ST segment elevation ≥1mm (0.1 mV) in two or more contiguous limb leads or ≥2mm (0.2 mV) in ) in one or more contiguous precordial leads OR
3. New or presumed new left bundle branch block (LBBB) OR
4. ST segment depression ≥1mm (0.1 mV) in two or more contiguous leads (not known to be pre-existing or due to a known cause such as LV hypertrophy or digoxin) OR
5. Troponin T or I greater than the laboratory upper normal limit.
2. Referred for urgent or emergency PCI AND Thrombus burden of TG 4 or above OR TIMI flow grade of 1 or less in at least one native infarct related artery following either
1. Manual aspiration thrombectomy OR
2. Balloon Angioplasty OR
3. AngioJet RT OR
4. Patient having deferred PCI due to heavy thrombus but continue to demonstrate recalcitrant thrombus upon repeat angiography.
Exclusion Criteria:
Subjects meeting any of the exclusion criteria listed below will be excluded from this study:
1. Age ≤ 21 years
2. Cardiogenic shock
3. killip class 3 or above at presentation
4. Known relative contraindications for the use of Solitaire:
1. Prior stent in infarct related artery
2. Significant proximal stenosis OR Ostial lesion at angiography
3. Extensive calcification
5. Life expectancy less than six months due to non-cardiac condition
6. Participants categorised as vulnerable subjects (ex: prisoners, pregnant women, and mentally disabled persons)
7. Patients at high risk of being lost to follow up (ex: non-residents)
8. Participation in any study with an investigational drug or device within the last 30 days
9. Patients who are unable to provide informed consent prior to any procedure .
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
80 Years
Study:
NCT04692402
Study Brief:
Protocol Section:
NCT04692402