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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02698358
Other study ID # 1-2015-0075
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 2015
Est. completion date January 2021

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- 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)


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Epic stent (Boston Scientific)


Locations

Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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