Iliac Artery Disease Clinical Trial
Verified date | January 2019 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
- Prospective, single-arm, multi-center registry study
- A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion
criteria will be included.
- Patients will be followed clinically for 12 months after the procedure.
- Duplex ultrasound, CT or catheter-based angiography follow-up according to participating
hospital's protocol will be performed at 12 months.
- Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12
months.
- Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)
Status | Active, not recruiting |
Enrollment | 68 |
Est. completion date | January 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Age 19 years of older 2. Symptomatic peripheral artery disease: - Moderate or severe claudication (Rutherford category 2 or 3) - Critical limb ischemia (Rutherford category 4) 3. Iliac artery lesions with stenosis > 50% 4. ABI <0.9 5. Patients with signed informed consent Exclusion Criteria: 1. Acute critical limb ischemia 2. Severe critical limb ischemia (Rutherford category 5 or 6) 3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents 4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment) 5. Bypass graft lesions 6. Age > 85 years 7. Severe hepatic dysfunction (> 3 times normal reference values) 8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis 9. LVEF < 40% or clinically overt congestive heart failure 10. Pregnant women or women with potential childbearing 11. Life expectancy <1 year due to comorbidity 12. Untreated proximal inflow disease of aorta or the ipsilateral iliac arteries (more than 50% stenosis or occlusion) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary patency | Absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months | 12 months | |
Secondary | Target lesion revascularization rate | 12 months | ||
Secondary | Stent fracture rate | 12 months | ||
Secondary | Quality of life by standardized questionnaires | 12 months |
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