IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease (ICARUS)

IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease (ICARUS Trial); A Feasibility Study

Objectives: 1) To evaluate the feasibility of using intravascular ultrasound to assess lesion morphology, select an appropriate stent size and landing zone 2) To compare the primary patency rates after intra vascular imaging-guided versus angiography-guided stent implantation for the treatment of fermoropopliteal artery segment lesions.

Hypothesis: One of the key determinants of the device failure is inappropriate landing zone, selection of smaller stent relative to the reference vessel diameter, and lack of high-pressure post-dilatation in a necessary post-stent segment. Therefore, intravascular ultrasound-guided selection of appropriate landing zone, stent size and balloon size for high pressure post-dilation may maximize the benefits of stent use and improve patency duration. the investigators hypothesize that intravascular ultrasound-guided stent implantation is superior to angiography-guided stent implantation with respect to 12 months primary patency in patients with significant femoropopliteal disease

Study Overview

• Status: Completed
• Conditions: Femoropopliteal Disease
• Intervention / Treatment: Device: intravascular ultrasound-guided group; Device: angiography-guided group

Detailed Description

This is a prospective, open-label, randomized comparison feasibility trial involving patients with significant femoropopliteal disease who are undergoing drug-eluting stent (paclitaxel-eluting, durable-polymer-coated Eluvia stent) implantation. Patients with symptoms attributable to limb ischemia are eligible for enrollment if the culprit lesions are suitable for stent implantation based on angiographic findings. The detailed information for inclusion and exclusion criteria is described below in session 7. Patients meeting inclusion criteria without any exclusion criteria will be randomized to either intravascular ultrasound-guided or angiography-guided group immediately before the endovascular intervention. In the intravascular ultrasound-guided group, intravascular ultrasound will be either automatically (1 mm/sec) or manually (5-10 mm/sec) pulled back at a constant speed according to the lesion length. Stent size and length are selected by information acquired from on-line intravascular ultrasound examination, and adjunct high-pressure dilation is performed to achieve stent optimization based on the intravascular ultrasound finding. For the selection of the landing zone and stent length, intravascular ultrasound and fluoroscopy images should be recorded simultaneously to link intravascular ultrasound images with location preferably using a ruler. For the selection of stent size and assessment of stent optimization, external elastic membrane area (EEM) before ballooning and minimal stent area (MSA) (i.e, the smallest cross-sectional area within the stent) after post-dilation are assessed. intravascular ultrasound is used at any step of the procedure before, during, or after stenting. However, image examination is mandatory before and after stenting. In the angiography-guided group, stent size and length are chosen by visual estimation, and adjunctive high-pressure dilation is performed if an optimal result, defined as angiographic residual diameter stenosis of less than 30% by visual estimation and the absence of angiographically detected dissection, was not achieved. Stent size is chosen at the operator's discretion in both groups, with diameters 1 or 2 mm larger than the reference diameter assessed either by intravascular ultrasound or visual estimation.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea
    • Inje University Busan Paik Hospital
  • Daegu, South Korea
    • Veterans Hospital
  • Seoul, South Korea
    • Asan Medical Center
  • Seoul, South Korea
    • Kangbuk Samsung Hospital
  • Seoul, South Korea
    • Konkuk University Medical Center
  • Seoul, South Korea
    • Severance Cardiovascular Hospital
  • Seoul, South Korea
    • Veterans Health Service Medical Center
  • Suwon, South Korea
    • Ajou University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intravascular ultrasound-guided group; In the intravascular ultrasound-guided group, intravascular ultrasound will be either automatically (1 mm/sec) or manually (5-10 mm/sec) pulled back at a constant speed according to the lesion length. Stent size and length are selected by information acquired from on-line intravascular ultrasound examination, and adjunct high-pressure dilation is performed to achieve stent optimization based on the intravascular ultrasound finding	Device: intravascular ultrasound-guided group; intravascular ultrasound use
Active Comparator: angiography-guided group; In the angiography-guided group, stent size and length are chosen by visual estimation, and adjunctive high-pressure dilation is performed if an optimal result, defined as angiographic residual diameter stenosis of less than 30% by visual estimation and the absence of angiographically detected dissection, , was not achieved	Device: angiography-guided group; angiography-guided use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patency at 12 months after treatment	peak systolic velocity ratio 2.4 or lower as assessed by the duplex ultrasound, in the absence of clinically driven target lesion revascularization or bypass of the target lesion.	12 month after randomization
Number of procedure related death	procedure related death through 30 days post-procedure	30 Days post procedure
Number of major amputation of the target limb or target-lesion revascularization	major amputation of the target limb through 12 months, or target-lesion revascularization through 12 months	12 month after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
technical success	deployment of the stent to the target lesion to achieve residual angiographic stenosis ≤30%	within 24 hours
procedural success	technical success without major adverse events	within 24 hours
Rutherford category score	Stage 0 - Asymptomatic; Stage 1 - Mild claudication; Stage 2 - Moderate claudication; Stage 3 - Severe claudication; Stage 4 - Rest pain; Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot; Stage 6 - Severe ischemic ulcers or frank gangrene	12 month after randomization

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Pil Hyung Lee, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Actual): February 26, 2026
• Study Completion (Actual): February 26, 2026

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2019-1514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No