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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT02119767
Eligibility Criteria:
Inclusion Criteria:
1. Subjects that are candidates for percutaneous transluminal interventional coronary procedures
2. Subjects undergoing elective PCI
3. Subjects presenting for PCI after NSTEMI
4. Subjects who have been preloaded with dual antiplatelet therapy (aspirin and clopidogrel (or prasugrel or ticagrelor)) as per usual local PCI practice.
5. Subjects who are willing and able to sign an informed consent.
Exclusion Criteria:
1. Subjects for whom the LBS is contra-indicated:
1. The LBS is contraindicated for use in severely stenosed, excessively tortuous or calcified coronary vessels.
2. The LBS is contraindicated in coronary vessels with a reference diameter of less than 2.5 mm.
3. The LBS is contraindicated for use in regions of coronary vessels that contain a stent.
4. The LBS is contraindicated for use in the carotid arteries, cerebral vessels or any of their side branches.
5. The LBS is contraindicated for use with patients in whom anticoagulant or antiplatelet therapy is contraindicated, or have uncorrected bleeding disorders or an allergy to heparin.
6. Use of the LBS is contraindicated in patients with ongoing sepsis that is considered relevant to cardiac catheterization.
7. The LBS is contraindicated for use in the acute phase of an ST Segment Elevation Myocardial Infarction, in patients with severe hemodynamic instability or shock.
8. The LBS is contraindicated for use in the presence of angiographic evidence of intracoronary thrombus.
2. Subjects who are unwilling or unable to sign an informed consent
3. Subjects undergoing immunosuppressive therapies
4. Severe left ventricular dysfunction (left ventricular ejection fraction \<30%)
5. Cardiogenic shock
6. PCI target in left main stem
7. PCI target lesion with low pre-procedure chance of success or high pre-procedure risk of complication (e.g. chronic total occlusion, thrombus load)
8. Subjects \<18 years (there is no upper age limit but there is a requirement that patients are considered to be "fit" enough by the operating cardiologist for the LBS procedure to not cause significant additional risk)
9. Pregnancy
10. Contraindication to dual antiplatelet therapy or inability to take dual antiplatelet therapy for at least 4 weeks post-procedure
11. Serum creatinine above 125 µmol/L.(i.e. the upper limit for normal)
12. Subjects on warfarin at the time of procedure
13. Subjects with active chronic inflammatory disease, e.g. systemic lupus erythematosus, rheumatoid arthritis, seropositive arthropathies and known seropositivity to HIV, Hepatitis B or Hepatitis C.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02119767
Study Brief:
Protocol Section:
NCT02119767