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:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT06669195
Eligibility Criteria:
Inclusion Criteria:
* Radiography inclusion criteria
1. the angiography identified a severely calcified lesion with acute stent under-expansion, i.e., residual stenosis \>20% after stenting and 16-atm dilatation with a post-dilatation balloon;
2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤30 mm (visual assessment);
General inclusion criteria
1. subjects at the age between ≥18 and ≤80 years old;
2. patients with symptoms or evidence of myocardial ischaemia;
3. subjects are willing to participate in the study, sign informed consent form, and accept clinical and angiography follow-up after PCI.
Exclusion Criteria:
* Radiography exclusion criteria
1. in-stent lesions;
2. For the left main disease and bifurcation lesion (branch vessel diameter shall be ≥ 2.5mm);
3. Target lesions were total occlusive lesions (acute or chronic), long lesions (\>30 mm), lesion vessel reference diameters \>4.0 mm, and lesion angiomatous dilatation;
General inclusion criteria
1. Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;
2. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
3. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
4. Patients with severe renal failure(eGFR\<30ml/minute) or such medical history, failure to comply with angiography conditions;
5. Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;
6. Patients who plans to accept selective operation within 1 year;
7. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
8. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06669195
Study Brief:
Protocol Section:
NCT06669195