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 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT04749732
Eligibility Criteria:
Inclusion Criteria:
1. PAD with IC (Fontaine II ou Rutherford 1-3) due to atherosclerotic disease;
2. ABI below 0.9 at rest or below 0.73 after exercise (20% decrease);
3. Age range between 50 and 80;
4. MWD in treadmill test between 50 and 500 meters;
Exclusion Criteria:
1. Asymptomatic PAD;
2. Critical Ischemia (Fontaine III/IV or Rutherford 4-6);
3. Previous lower extremity vascular surgery, angioplasty, or lumbar sympathectomy;
4. Any condition other than PAD that limits walking;
5. Miocardial Infarction or Unstable Angina in the last 6 months;
6. Inability to obtain ABI measure because of non-compressible vessels;
7. Use of cilostazol and pentoxifylline initiated within 3 months before the investigation;
8. Active cancer, renal disease, or liver disease;
9. Severe chronic obstructive pulmonary disease (GOLD stage III/IV);
10. Severe congestive heart failure (NYHA class III/IV);
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04749732
Study Brief:
Protocol Section:
NCT04749732