Comparing imaging techniques for stent implantation in leg artery disease
IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease (ICARUS Trial); A Feasibility Study
This study is testing if using ultrasound to guide stent placement in leg arteries helps patients with artery disease have better results than using the usual imaging method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 8 sites (Busan and 7 other locations) |
| Trial ID | NCT05805280 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the feasibility of using intravascular ultrasound to guide stent implantation in patients with significant femoropopliteal artery disease. It compares the outcomes of stent placement guided by intravascular ultrasound versus traditional angiography. The study aims to determine if ultrasound guidance can improve stent selection and placement, potentially leading to better long-term patency rates. Patients will be randomized into two groups to assess the effectiveness of each imaging technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 85 with significant femoropopliteal artery lesions suitable for stent implantation.
Not a fit: Patients with existing stents in the target vessel or those who have had recent interventions in the same area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved stent performance and longer-lasting relief from symptoms of limb ischemia for patients.
How similar studies have performed: Previous studies have shown promising results with imaging-guided interventions, suggesting potential benefits of this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men or women at least 20 years up to 85 years of age * Intermittent claudication or tissue loss suitable for elective endovascular intervention (Rutherford category 2,3,4, or 5) * Significant native superficial femoral or proximal popliteal artery lesions suitable for stent implantation. Restenotic lesions can be enrolled at least 12-month after the index procedure uding plain balloon or drug-coated balloon. * Total lesion length of 30 to 220 mm * Reference vessel diameter of 4 - 6 mm * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: * Existence of a stent in the target vessel * Previous use of atherectomy device in the target vessel * Use of drug-coated balloon in the target vessel within 12-month * Untreatable significant stenosis or occlusion (diameter stenosis ≥70%) in all 3 infrapopliteal arteries (patient can be enrolled if at least 1 patent outflow artery to the ankle (diameter stenosis \<50%) can be achieved by treatment during the index procedure) * A known intolerance or contraindication to antiplatelet drugs (aspirin or clopidogrel) * Unwillingness or inability to comply with the procedures described in this protocol.
Where this trial is running
Busan and 7 other locations
- Inje University Busan Paik Hospital — Busan, Korea, Republic of (Recruiting)
- Veterans Hospital — Daegu, Korea, Republic of (Not_yet_recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Kangbuk Samsung Hospital — Seoul, Korea, Republic of (Not_yet_recruiting)
- Konkuk University Medical Center — Seoul, Korea, Republic of (Recruiting)
- Severance Cardiovascular Hospital — Seoul, Korea, Republic of (Not_yet_recruiting)
- Veterans Health Service Medical Center — Seoul, Korea, Republic of (Recruiting)
- Ajou University Medical Center — Suwon, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Pil Hyung Lee, MD — Asan Medical Center
- Study coordinator: Ji Sue Hong, RN
- Email: sue5165@naver.com
- Phone: 82 2-2045-3798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.